Reported trial results for Peripheral Arterial Disease
Every Peripheral Arterial Disease trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
113 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT05992896 · results posted 29 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05992896) compared two groups of surgical patients — one receiving liposomal bupivacaine (a longer-acting local anaesthetic delivered in tiny fat particles) and one receiving a placebo (an inactive substitute). Only 3 people in total were enrolled: 1 in the liposomal bupivacaine group and 2 in the placebo group. Of those, 1 person in the placebo group did not complete the trial. The study was measuring how much pain relief medication (specifically opioid-type medicines, expressed as a "morphine equivalent" — a standard way of comparing different opioid doses) participants used at 12, 24, 48, and 72 hours, and at 30 days after the injection. It also measured participants' own rating of how well they felt they had recovered at 14 days, using a 15-question survey scored from 0 to 150, where higher scores mean better recovery. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary outcomes (opioid use at each time point) nor the secondary outcome (quality of recovery score at 14 days). The measurements section for every outcome was empty. It is also worth noting that with only 3 participants enrolled, this trial was extremely small — far smaller than what would typically be needed to draw any meaningful conclusions from results, had they been reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00707876 · results posted 16 April 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 119 participants across three groups (called Cohort 1, Cohort 2, and Cohort 3), with 40, 39, and 40 people starting in each group respectively. The trial was comparing two types of MRI scan — one using a contrast agent called ferumoxytol (referred to as VE-MRI) given at three different dose levels, and one done without any contrast agent (noncontrast MRA) — to see how accurately each type of scan could identify problem areas in blood vessels. The main things being measured were how often each scan correctly spotted a real problem ("sensitivity," meaning the percentage of true positives correctly identified) and how often it correctly ruled out a problem that wasn't there ("specificity," meaning the percentage of true negatives correctly identified). The reported data shows that for the ferumoxytol-enhanced MRI scans, sensitivity figures across the three dose groups and multiple readers ranged roughly from about 72% to 83%, while specificity figures ranged from roughly 61% to 83%. For the noncontrast MRI scans, the reported sensitivity figures were lower, ranging from roughly 46% to 63%, and specificity ranged from roughly 47% to 57%. The secondary outcomes also reported "positive predictive values" (how often a positive result was a true positive) and "negative predictive values" (how often a negative result was a true negative). For the ferumoxytol MRI, positive predictive values ranged from roughly 47% to 63%, and negative predictive values ranged from roughly 82% to 91%. For the noncontrast MRI, positive predictive values ranged from roughly 32% to 41%, and negative predictive values ranged from roughly 68% to 76%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06112054 · results posted 10 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06112054) enrolled 19 participants, all of whom were placed into a single group to undergo the study procedure using a device called the Clotild® Smart Guidewire System (CSGS). This is a specialised guidewire — a thin, flexible wire used during artery procedures — that was being tested for its ability to take electrical measurements inside blocked or narrowed arteries. Seventeen of the 19 participants completed the trial, and two did not complete it (the reasons were not detailed in the reported data). The reported data shows that the main thing being measured was whether the CSGS could successfully record at least one valid electrical (impedance) reading inside the artery blockage during the procedure. Impedance is a measure of how easily an electrical signal passes through tissue. According to the results reported on ClinicalTrials.gov, all 17 participants who completed the study had at least one valid reading recorded, meaning the procedural success count was reported as 17 out of 17. The reported data also shows results for a secondary measurement — whether the device could tell different types of tissue apart, such as fresh blood clot versus other tissue types. Due to limitations in the data collected, the researchers could only assess this for one comparison: fresh clot versus everything else. A computer model was used to assign a probability score. The reported data shows that, for measurements the treating doctor labelled as fresh clot, the model gave a mean (average) probability score of approximately 0.38 (on a scale of 0 to 1), while measurements the doctor labelled as non-clot tissue received a mean probability score of approximately 0.03. No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04007055 · results posted 13 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04007055) enrolled 31 people in total — 17 in the experimental group, who were screened and treated for something called "high platelet reactivity" (HPR, meaning their blood platelets were not responding as expected to blood-thinning medication), and 14 in a control group who received standard care based on existing guidelines. By the end of the study, 12 people in each group had completed the trial. The trial was measuring how well blood vessels stayed open after a procedure, as well as tracking serious events such as amputation, heart attack, stroke, or death. The reported data shows that for the main outcome — keeping the treated blood vessel open without needing another procedure or the vessel becoming blocked or significantly narrowed — 3 participants in the experimental group and 2 participants in the control group met this measure. For the secondary outcomes, the reported data shows that 0 people in the experimental group and 2 people in the control group had a lower limb amputation during the study period. One person in each group experienced a major cardiovascular event (such as a stroke, heart attack, or death). A smaller sub-analysis looked at whether two different methods of testing for HPR gave matching results; the reported figures for this comparison show 0 matched results in one category and 2 versus 9 in another, though the full detail of this comparison was not clearly broken down in the submitted data. It is worth noting that this was a very small trial, and the numbers involved are too limited to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05208905 · results posted 26 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05208905) enrolled 9 people who received a device called the Esprit BTK — a stent (a small tube placed inside a blood vessel) that releases a drug called everolimus. Eight of the 9 participants completed the study; one did not. The trial was measuring how everolimus moved through participants' blood after the device was implanted — specifically, how much of the drug got into the bloodstream, how quickly it peaked, and how long it took to clear. Blood samples were taken at multiple time points over 60 days, starting from just before implantation right through to 60 days afterwards. The reported data shows the following figures for everolimus in the blood: the highest concentration reached (called the "peak level") was 21.3 ng/mL (nanograms per millilitre — a very small unit of measurement). This peak was reached very quickly, at around 0.33 hours (roughly 20 minutes) after implantation. The total amount of drug the body was exposed to in the first 24 hours — a measure of overall exposure over that period — was reported as 192.3 h·ng/mL. The total exposure measured up until the last detectable level during the 60-day study was 586.2 h·ng/mL, and when mathematically extended to account for any remaining drug beyond that point, the figure was 612.3 h·ng/mL. The reported data also shows that the drug's "half-life" — meaning the time it took for the concentration in the blood to fall by half — was approximately 109 hours (about 4.5 days). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04536038 · results posted 24 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04536038) involved a total of 5,176 people, split into two groups: 3,909 in an "opt-in" group and 1,267 in an "opt-out" group. The trial was looking at two different ways of recruiting people into a follow-on study called GAMEPAD — one where participants had to actively choose to join (opt-in), and one where they were automatically included unless they chose not to be (opt-out). All participants in both groups completed the study period with no drop-outs recorded. The reported data shows that the main thing being measured was how many people from each group went on to actually enrol in the GAMEPAD intervention study. Out of the 3,909 people in the opt-in group, 39 enrolled in GAMEPAD. Out of the 1,267 people in the opt-out group, 45 enrolled. The trial also tracked how many of those who enrolled in GAMEPAD did not finish it. The reported data shows that in the opt-in group, a proportion of 0.154 (roughly 15 out of every 100 people) did not complete the study, while in the opt-out group, a proportion of 0.067 (roughly 7 out of every 100 people) did not complete it. No additional outcome measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01794572 · results posted 12 December 2025
According to the results reported on ClinicalTrials.gov, this trial tested a radiation-based treatment called Total Bone Marrow Irradiation (TBMI) in people with blood cancer. The trial was designed to find the highest radiation dose that could be given without causing unacceptable side effects — this is called a "dose-limiting toxicity" or DLT. Participants were placed into groups receiving increasing total radiation doses: 8 Gy, 10 Gy, 12 Gy, or 14 Gy. A fifth planned group at 16 Gy had no participants enrolled. In total, 13 people took part — 3 at the 8 Gy level, 3 at 10 Gy, 6 at 12 Gy, and 1 at 14 Gy — and all who started the trial completed it. The reported data shows that, for the primary goal of identifying the maximum tolerated dose and any serious side effects, 1 out of 6 participants in the 12 Gy group experienced a dose-limiting toxicity, while no such events were reported in the 8 Gy, 10 Gy, or 14 Gy groups. For the secondary measure looking at the safety profile and identifying a recommended dose for a future larger trial, the reported data shows zero participants recorded as having dose-limiting toxicities across all groups, though the full detail of the safety findings was not comprehensively broken down in the submitted numbers. Regarding a pre-specified exploratory measure of how well the treatment appeared to be working — looking at complete responses and very good partial responses on imaging scans — the reported data shows that across the four dose groups, small numbers of participants fell into each response category, but a full breakdown by response type was not clearly separated in the submitted data, and figures for the 16 Gy group were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05103280 · results posted 31 October 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people who had difficulty walking due to a condition affecting blood flow to the legs (known as claudication). All 10 participants completed the study. The trial was a single-arm study, meaning there was no comparison group — everyone received the same type of intervention. Participants were given a choice between two types of specially designed assistive shoes (either a carbon fibre shoe or a spring-loaded shoe) and wore their chosen pair for three months. The study measured how far participants could walk on a treadmill, how comfortable the shoes felt, and several other physical measures, both before and after the three-month period. The reported data shows that before the intervention, participants walked an average of around 263 metres on the treadmill test, and after three months this figure was reported as approximately 290 metres. For shoe comfort, rated on a scale of 0 to 10, the three shoe options received average comfort ratings of 5.5, 5.9, and 6.6 at the start of the study. The reported data also shows changes in other measures after the three months: the force participants exerted on the treadmill (vertical ground reaction force) was reported as going from about 769 Newtons to about 845 Newtons; minimum muscle oxygen levels were reported as changing from about 36.8% to 40.0%; average daily steps were reported as going from approximately 4,099 to 4,741 steps per day; and the participants' self-rated effort during the treadmill test (on a scale of 6–20) was reported as changing from 12.6 to 13.25. No data was reported for any safety outcomes. It is worth noting that because this was a very small study of only 10 people and had no comparison group, the numbers on their own are limited in what they can tell us. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04440839 · results posted 4 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04440839) enrolled 116 people in the telemedicine group and, notably, zero participants in the standard care comparison group. Because no one was enrolled in the standard care group, the trial appears to have run as a single-group study in practice. The trial was measuring how quickly people with wounds received specialist attention, how long it took to have a procedure to improve blood flow to the affected leg, how long wounds took to heal, and whether any amputations occurred — all within the telemedicine group. The reported data shows that, on average, participants in the telemedicine group waited about 66 days from when their wound was first identified until they saw a specialist. The reported time from wound identification to a blood-flow procedure (revascularisation) was about 71 days on average. For wound healing, the reported average time was approximately 174 days. Regarding amputations, the data lists four separate figures — 83, 20, 5, and 5 participants — though the breakdown of exactly what each figure represents (for example, no amputation versus minor versus major) was not clearly labelled in the submitted data, so a precise plain-English breakdown cannot be provided without risk of misrepresentation. Of the 116 people who started, 113 completed the study and 3 did not. It is also important to note that because the standard care group reported zero participants throughout, no side-by-side comparison between telemedicine and standard care can be drawn from these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03784729 · results posted 20 August 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 98 people in an acupuncture group and 98 people in a sham (fake) acupuncture group — 196 participants in total. The trial was measuring changes in low back pain-related disability using a questionnaire called the Modified Roland-Morris Disability Questionnaire (RMDQ). This is a 24-question survey where each question asks whether back pain affected a specific daily activity; scores run from 0 to 24, with higher scores meaning greater difficulty. By the end of the study, 86 people in the acupuncture group and 88 in the sham group had completed the trial. The reported data shows that, at the primary time point, the acupuncture group's average RMDQ score dropped by 4.3 points from where it started, while the sham acupuncture group's average score dropped by 3.0 points. At two later follow-up time points reported as secondary outcomes, the acupuncture group's scores dropped by 4.6 and then 4.8 points from the starting point, compared with drops of 2.6 and 3.0 points in the sham group. The trial also tracked what percentage of participants had their RMDQ score fall by at least 30% from their starting level — a threshold sometimes used to indicate a meaningful change. The reported data shows that across three time points, between 55% and 66% of people in the acupuncture group reached that 30% reduction, compared with between 32% and 45% in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05058456 · results posted 8 June 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in a single group (meaning everyone received the same treatment — there was no comparison group). The trial was testing a catheter-based procedure called intravascular lithotripsy (IVL), using a device called the Javelin IVL Catheter, for treating blockages in leg arteries. The trial measured two main things: whether the procedure caused any serious health events within 30 days, and whether the procedure successfully opened the blocked artery. Not all participants stayed in the trial to the end — 29 completed the full follow-up period, with 6 not completing the study for various reasons. The reported data shows that, of the 35 people who started the trial, 1 experienced what the trial defined as a "major adverse event" within 30 days — a combined measure that included cardiovascular death, needing an unplanned repeat procedure on the treated artery, or a serious limb amputation. For the procedure success measure, all 35 participants were reported to have had the artery opened to an acceptable level (less than 50% blockage remaining) without a serious tear in the artery wall immediately after the procedure. A secondary measure used a stricter target (less than 30% blockage remaining), and the reported data shows 25 out of 35 participants met that standard. The reported data also shows that 0 participants experienced serious complications such as artery tears, punctures, or sudden artery closure during the procedure, and that 30 out of 35 participants met the success threshold specifically after an additional balloon step. The device itself was reported to have been successfully used across 41 catheters deployed during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02900924 · results posted 17 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02900924) enrolled 507 people who received a device called the BioMimics 3D Stent, which is placed inside a blood vessel in the leg to help keep it open. The trial was a single-group study — meaning everyone received the same treatment, with no comparison group. The study tracked participants at 30 days, 12 months, and 24 months. By the end of the study, 398 participants were recorded as having completed it, while 109 did not complete all follow-up visits. The reported data shows that for the main safety measure — the number of people free from a serious combined event (death, major amputation of the treated leg, or a repeat procedure on the treated area) within 30 days — the numbers recorded across different counting points were 489, 492, 492, and 491 participants out of those followed up. For the main effectiveness measure, 396 participants were reported as not having needed a repeat procedure on the treated area through 12 months. Looking at secondary measures, 501 participants were reported to have had a satisfactory technical result at the end of their procedure (meaning the narrowing in the vessel was reduced to 30% or less), and 494 met the broader definition of procedural success, which also required the absence of certain serious events within 72 hours. The reported data also includes figures for adverse events (any unwanted medical occurrence) tracked across the 24-month study period, with 255 participants recorded as experiencing at least one adverse event of any kind over that time, among other specific subcategories reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04120610 · results posted 11 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04120610) enrolled 195 people in total — 52 healthy participants and 143 people with peripheral artery disease (PAD), a condition where the arteries in the legs become narrowed. All 52 healthy participants completed the study, while 83 of the 143 PAD participants completed it (60 did not complete the study, though the reasons were not detailed in the data). The trial was measuring how well a device called FlowMet-R — which measures blood flow in the legs — could identify whether someone had PAD, a severe form called critical limb ischaemia (CLI, meaning very poor blood flow to the limbs), or whether they were likely to need a procedure on their blood vessels in the future. The reported data shows that, for the primary goal of diagnosing PAD, the FlowMet-R model produced figures called sensitivity (how often it correctly identified people who did have the condition) and specificity (how often it correctly identified people who did not). These ranged roughly from 0.78 to 0.87 across different definitions of PAD and different time points, with an overall summary score (called the area under the curve, or AUC — a measure from 0 to 1 where 1 would mean perfect accuracy) ranging from 0.52 to 1.00 across the different groups and time points. For predicting whether someone would go on to need a vascular procedure within 3 or 6 months, the reported sensitivity and specificity figures ranged from approximately 0.49 to 0.60, with AUC values between 0.52 and 0.56. For detecting significant artery narrowing (greater than 50% blockage), the reported sensitivity, specificity, and AUC were each 0.61, 0.61, and 0.63 respectively. The reported data also shows a correlation between the device's measurements and changes in standard blood pressure ratio tests (ABI and TBI) over time, though the correlation values themselves were small (ranging from 0.02 to 0.10). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03347383 · results posted 6 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 100 participants, all of whom received a combination treatment involving a drug-coated balloon (DCB) and a stent — two devices used together during a procedure on a narrowed blood vessel in the leg. The trial was designed to track how often participants needed a repeat procedure on the same section of vessel, as well as how well the vessel stayed open over time. Of the 100 people who started the study, 49 were recorded as having completed it, while 51 did not complete it (the reasons were not detailed in the submitted data). The reported data shows that for the primary goal — measuring how many participants were free from needing a clinically-driven repeat procedure on the treated vessel at 12 months — the number reported was 5 participants. For the secondary outcomes, technical success (being able to treat the blockage and leave less than 30% narrowing) was reported for 100 participants. The vessel remaining open without a repeat procedure (called "primary patency") was reported as 7 participants at 6 months and 8 participants at 12 months. The number of participants free from a repeat procedure at 6 months, 2 years, 3 years, 4 years, and 5 years was reported as 1, 10, 17, 20, and 25 respectively. Clinical success — meaning a participant's leg symptoms improved by at least one category on a standard scale — was reported at 84 participants at 1 month, declining over time to 25 participants at 60 months. A total of 226 serious adverse events (unexpected or significant medical events requiring attention) were recorded across the study period. It is worth noting that several of the reported numbers appear unusually low given the 100-person enrolment, and the submitted data does not provide enough context to explain all figures fully — for example, it is unclear whether missing participant data accounts for some results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04881110 · results posted 3 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in a group that received liraglutide (a medication used in diabetes and weight management) and 30 in a control group. Most participants completed the six-month study: 27 in the liraglutide group and 28 in the control group. The trial was primarily measuring blood oxygen levels in the lower leg — specifically, a reading called transcutaneous oxygen pressure, which is a measure of how much oxygen is reaching the skin and tissues near the ankle. It also tracked a range of secondary measures including blood sugar control, body weight, BMI (a ratio of weight to height), and waist circumference. The reported data shows that after six months, the average transcutaneous oxygen pressure reading — the primary measure — was 54.2 mmHg (millimetres of mercury, the unit used for these readings) in the liraglutide group, compared with 43.4 mmHg in the control group. For the secondary measures, average HbA1c (a blood test reflecting blood sugar levels over roughly three months, expressed as a percentage) was 6.7% in the liraglutide group and 6.8% in the control group. Fasting blood glucose (a measure of blood sugar after not eating) was reported as 118.5 mg/dL in the liraglutide group and 117 mg/dL in the control group. Average weight was 78.5 kg in the liraglutide group and 80.7 kg in the control group. Average BMI was 28.7 in the liraglutide group and 27.7 in the control group. Average waist circumference was 108.9 cm in the liraglutide group and 104.1 cm in the control group. It is worth noting that the weight, BMI, and waist circumference figures represent the values recorded at six months; the trial description states these were intended to reflect change from the start of the study, but baseline (starting) figures were not separately reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05073510 · results posted 27 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 187 participants, with 186 completing the study and 1 not completing it. The trial was testing a device called the BlueDop Vascular Expert (BVE), which is designed to detect peripheral arterial disease (PAD) — a condition where blood flow to the limbs is reduced. The trial compared the BVE device's readings to two existing assessment methods: arterial duplex ultrasound (a standard imaging test) and ABPI (ankle-brachial pressure index, a test that compares blood pressure in the ankle to the arm). Results were recorded per limb rather than per person. The reported data shows that when compared to the duplex ultrasound, the BVE recorded 62 limbs as having significant PAD that the duplex also identified, 212 limbs as not having significant PAD that the duplex also did not identify, 14 limbs where BVE indicated significant PAD but the duplex did not, and 43 limbs where the duplex indicated significant PAD but the BVE did not. When compared to ABPI, the reported figures were 62 limbs agreeing on PAD present, 202 agreeing on PAD absent, 11 where BVE indicated PAD but ABPI did not, and 51 where ABPI indicated PAD but BVE did not. The reported data also shows that 74 limbs could not be assessed by the BVE device, and zero adverse events or serious adverse events were reported. On the question of how long each test took, the duplex ultrasound averaged around 17 minutes, the BVE around 15 minutes, and ABPI methods around 11 minutes. When vascular specialists and non-specialists both used the BVE, the reported data shows they agreed on results in approximately 88% of cases (that is, 0.88 out of a possible 1.0, where 1.0 would mean perfect agreement). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05250102 · results posted 30 October 2024
According to the results reported on ClinicalTrials.gov, this trial involved 23 participants and all 23 completed the study — none dropped out. The trial was looking at how closely readings from a Nellcor pulse oximeter (a device that estimates the level of oxygen in the blood by shining light through the skin) matched readings taken directly from blood samples. The goal was to see how much difference, if any, existed between the two measurement methods. The reported data shows that the main analysis used something called a Bland-Altman analysis, which is a standard way of comparing two different measuring methods by looking at the average gap between their results and how consistently that gap appears. For the Nellcor pulse oximeter, two figures were reported: a bias (the average difference between the two methods) of 0.151%, and a related figure of 0.434% — both expressed as percentage differences in the mean. These numbers represent how far apart the pulse oximeter readings were from the direct blood measurements on average. No secondary outcome results were reported in the submitted data. It is worth noting that the reported data does not include a full breakdown of all results, and some details — such as what the 0.434% figure specifically refers to — were not clearly labelled in the submitted information, so those details cannot be explained further here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05837481 · results posted 16 October 2024
According to the results reported on ClinicalTrials.gov, this trial involved 30 people in total — 15 in a guided meditation group and 15 in a control group (who did not receive the meditation). One person in the control group did not complete the study, leaving 14 who finished. The trial was looking at whether it was practical and feasible to introduce guided meditation sessions before and around the time of surgery, and also measured participants' feelings of anxiety and their awareness of their own bodily sensations (called "interoceptive attention"). The reported data shows that all 15 participants in the meditation group completed both rounds of the meditation sessions, which met the trial's pre-set feasibility target of more than 80% completion. For anxiety, which was measured using a questionnaire called the STAI-6 (scored from 6 to 24, where higher numbers mean more anxiety), scores at one time point were reported as 11.93 for the meditation group and 11.86 for the control group. At a second time point, the reported scores were 8.33 for the meditation group and 9.42 for the control group. For bodily awareness, measured using a questionnaire called the MAIA Noticing subscale (scored from 0 to 20, where higher numbers indicate greater awareness), the meditation group scored 12.8 and the control group 10.7 at one point, and 14.3 versus 11.5 at a second point. The trial's design means these two time points likely reflect measurements taken before and after the intervention period, though the data as reported does not label them explicitly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04227899 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04227899) enrolled 261 people in total — 173 in the Esprit BTK group and 88 in the balloon angioplasty (PTA) group. The trial was looking at a device-based treatment for blocked arteries below the knee, and it measured two main things: how often serious limb events (such as major amputation or the treated vessel becoming completely blocked) were avoided, and how often serious safety events (major limb problems or death around the time of the procedure) were avoided. The reported data shows the following numbers for the primary (main) outcomes. For the combined measure of limb preservation and keeping the treated vessel open, 111 out of 173 participants in the Esprit BTK group and 31 out of 88 in the PTA group met that combined goal. For the safety measure — being free from major adverse limb events or death around the time of the procedure — 155 out of 173 Esprit BTK participants and 85 out of 88 PTA participants were reported as meeting that standard. For the secondary (additional) outcomes, 35 out of 173 Esprit BTK participants and 35 out of 88 PTA participants showed significant re-narrowing of the treated area. For the second additional measure — being free from amputation, complete vessel blockage, or a repeat procedure driven by symptoms — 124 out of 173 Esprit BTK participants and 49 out of 88 PTA participants met that combined goal. It is worth noting that 20 participants in the Esprit BTK group and 10 in the PTA group did not complete the study, and the results above reflect only those for whom data was available and reported. No further detail on the reasons for non-completion or the timing of all measurements was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02607033 · results posted 17 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02607033) involved 18 people in total, split into two groups of nine: one group took part in both exercise and weight loss activities, and the other group did exercise only. The trial was measuring changes in leg pain during walking, blood flow to the legs, physical mobility, and muscle and fat composition in the calf muscles, all compared before and after the programme. Seven out of nine participants in the exercise-and-weight-loss group completed the study, while only two out of nine completed it in the exercise-only group. The reported data shows that, for the time it took for calf pain to first appear during a treadmill walk, the exercise-and-weight-loss group saw a reported change of 396 seconds, compared to 140 seconds in the exercise-only group. For the ankle brachial index — a ratio comparing blood pressure in the arms and legs used to estimate blood flow — the exercise-and-weight-loss group showed a reported change of +0.04, while the exercise-only group showed a change of −0.16 (noting that, as explained in the trial data, a negative number here indicates an improvement in this particular measure). For the physical performance test — a mobility assessment scored from 0 to 36, where higher scores reflect better function — the reported post-programme median scores were 33 for the exercise-and-weight-loss group and 31 for the exercise-only group. The reported data shows that no results were provided for the measure of muscle and fat composition in the calf muscles — this outcome was not reported in the data submitted to ClinicalTrials.gov. It is also worth noting that the small number of participants, and the fact that most people in the exercise-only group did not complete the trial, means the numbers above should be read with that context in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03363165 · results posted 30 May 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people in total — 18 in the placebo group and 21 in the VM202 group. VM202 is a gene therapy delivered by injection that was being investigated for peripheral artery disease, a condition that can cause pain and difficulty walking due to reduced blood flow in the legs. The trial tracked participants over 12 months and measured things like how far they could walk, blood flow in their calf muscles, and how they felt about their own walking ability and quality of life. The reported data shows that for the main measure — how far participants could walk in six minutes — the placebo group's distance increased by about 17 metres on average, while the VM202 group's distance increased by about 3.5 metres. For the treadmill walking time (a secondary measure), the placebo group's time went down slightly (about half a minute on average), while the VM202 group's time went up by about 1.7 minutes. Calf muscle blood flow, measured by MRI, increased by roughly 1.98 units in the placebo group and 2.68 units in the VM202 group. A muscle biopsy measure looking at specialised muscle repair cells showed a decrease of about 4.83 cells per 100 muscle fibres in the placebo group and an increase of about 3.45 in the VM202 group. For patient-reported walking ability (scored 0–100), scores rose by about 6.3 points in the placebo group and 8.3 points in the VM202 group. For the quality-of-life score (also 0–100), the placebo group rose by about 8.7 points and the VM202 group by about 3.2 points. Where participants did not complete follow-up visits, the data was not reported for those individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02374320 · results posted 21 May 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, and all 13 completed the study — none dropped out. The trial involved a single group of participants who received an injection called Exparel (a long-acting local anaesthetic delivered in tiny fat particles). The study was measuring two things: changes in the width (diameter) of two blood vessels in the forearm — the radial artery and the ulnar artery — before and after the injection, and self-reported pain levels at the start of the study and again at 30 days. The reported data shows that artery diameter was measured using an ultrasound device, in centimetres. For the radial artery, the average diameter before the injection was 0.16 cm, and one hour after the injection it was measured at 0.20 cm. For the ulnar artery, the average diameter before the injection was 0.19 cm, rising to 0.23 cm one hour after. For the pain measure, participants rated their pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The reported data shows the average pain score at the start of the study was 6.0, and the average score at 30 days was 5.2. No further breakdown of these figures was reported in the submitted data. It is worth noting that because there was only one group in this trial and no comparison group, the reported numbers reflect observations within that single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04060797 · results posted 20 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04060797) involved 38 people in total — 19 in a control group and 19 in an "EDN group." All 38 participants completed the study with no drop-outs. The trial was measuring changes in two things: the Ankle Brachial Index (ABI) — a simple ratio comparing blood pressure in the legs to blood pressure in the arms, where a higher number generally indicates better blood flow — and Transcutaneous Oxygen Pressure (TcPO2), a measure of how much oxygen is reaching the skin. Both were tracked at one week, three months, and six months after the procedure, with the change from each participant's starting (baseline) value being recorded. The reported data shows the following numbers for the primary outcome — the change in ABI at six months after the procedure: the control group had an average change of 0.24, while the EDN group had an average change of 0.44. For the secondary ABI measurements, at three months the reported changes were 0.28 (control) and 0.48 (EDN), and at one week they were 0.21 (control) and 0.28 (EDN). For the skin oxygen pressure (TcPO2) measurements, the reported changes at six months were 4.95 mmHg (control) and 15.68 mmHg (EDN); at three months, 5.58 mmHg (control) and 15.68 mmHg (EDN); and at one week, 5.16 mmHg (control) and 7.12 mmHg (EDN). The trial's own description notes that higher change values represent a better result for both measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02663518 · results posted 10 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02663518) tested a drug called ontorpacept (also known as PF-07901800 or TTI-621) in people with certain blood cancers. The trial ran in four parts, testing different doses of the drug either on its own or combined with other medicines (nivolumab or rituximab). In total, across all parts of the trial, the reported data shows that 273 people took part. The main things the trial was set up to measure were the number of participants who experienced medical events that appeared during treatment (called "treatment-emergent adverse events"), as well as serious versions of those events, and instances where side effects were severe enough to limit the dose that could be given. The reported data shows the following numbers for those key measurements. In the early dose-finding stage (Part 1, 18 participants across four dose levels), all 18 participants experienced at least one treatment-emergent medical event; serious treatment-emergent events were recorded in 1, 0, 1, and 2 participants across the four dose groups respectively. Dose-limiting events — meaning events considered serious enough to cap how much drug could be given — were recorded in 0, 0, 1, and 2 participants across those same groups. In the larger expansion stage (Parts 2 and 3, up to 200 participants), serious treatment-emergent events were reported in 43, 15, 2, and 13 participants across the four treatment groups. In the dose optimisation stage (Part 4, 31 participants across six dose groups), serious treatment-emergent events were reported in 1, 1, 2, 0, 3, and 3 participants per group; dose-limiting events were reported in 0, 0, 1, 0, and 2 participants (the data for one group in this last measure was not reported). Secondary outcome data — such as how the drug moved through the body and how tumours responded — was also collected, but the full numerical details were truncated in the available submission and cannot be fully described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03446027 · results posted 10 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03446027) enrolled 200 people in total — 102 in the control group and 98 in the device group. Of those, 78 control participants and 80 device participants completed the study. The trial was looking at whether a device made a difference to how far people could walk on a treadmill, compared to a control group, over a period of three months. It also measured quality of life using several questionnaires, and blood flow in a leg artery using ultrasound. The reported data shows that, for the main outcome — total walking distance on a treadmill — the control group started at an average of about 220 metres and reached about 328 metres at three months, while the device group started at about 243 metres and reached about 370 metres at three months. For the secondary walking measure (the distance at which leg pain or discomfort first appeared), the control group went from roughly 99 metres to 180 metres, and the device group went from roughly 106 metres to 211 metres. For blood flow in the leg artery (measured in cubic centimetres per minute), the control group started at about 297 and was at 281 at three months, while the device group started at about 300 and was at 297 at three months. The reported data shows several quality-of-life scores were recorded at multiple time points for both groups, with scores shifting modestly across the study period in both directions; however, the way the quality-of-life data was submitted makes it difficult to clearly match every score to a specific time point, so those figures should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03241459 · results posted 9 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03241459) enrolled 446 people in total — 222 received a device called the SurVeil drug-coated balloon (DCB) and 224 received a device called the IN.PACT Admiral DCB. Both are specialised balloon catheters used in a procedure to open a narrowed artery in the leg. The trial tracked participants over two years, with check-ins at 1, 6, 12, and 24 months. The main things being measured were whether the treated artery remained open without significant re-narrowing over 12 months, and a combined safety measure looking at freedom from certain serious events including death, major limb amputation, and the need to re-treat the same blood vessel. The reported data shows that for the primary measure of the artery staying open at 12 months, 82.2% of participants in the SurVeil DCB group and 85.9% in the IN.PACT Admiral DCB group met this outcome. For the primary safety measure — which tracked freedom from procedure- or device-related death within 30 days, and freedom from major amputation or the need to re-treat the target vessel within 12 months — the reported figures were 91.8% for the SurVeil DCB group and 89.8% for the IN.PACT Admiral DCB group. For several secondary measures, the reported data shows that at 30 days, 217 out of 222 SurVeil participants and 223 out of 224 IN.PACT participants were free from all-cause death, major amputation, and the need to re-treat the vessel. The reported data also shows that in terms of how well the devices performed during the procedure itself, 199 SurVeil participants and 208 IN.PACT Admiral participants met the definition of "device success" (meaning the balloon was delivered, used, and removed as intended with a good result), while 217 and 223 participants respectively met the definition of "technical success" (meaning the artery was sufficiently opened). Procedure success — which combined technical success with the absence of serious complications within 72 hours — was reported for 217 SurVeil participants and 222 IN.PACT Admiral participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02790931 · results posted 4 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02790931) enrolled 39 people in an intervention group and 39 people in a control group — 78 participants in total. The trial was measuring physical activity levels and walking speed in both groups. However, not everyone completed the study: 15 people in the intervention group and 19 people in the control group finished, meaning a notable number of participants did not complete the trial in each group. The reported data shows three primary measurements were taken. For daily physical activity (counted as steps per week), the intervention group averaged 8,744 steps per week compared to 7,373 steps per week in the control group. For self-selected walking speed — meaning the pace people naturally chose to walk at — the intervention group recorded 1.06 metres per second and the control group recorded 1.00 metres per second. For fast walking speed — meaning the quickest pace participants could manage — the intervention group recorded 1.68 metres per second compared to 1.49 metres per second in the control group. The reported data also listed three secondary outcomes — ulceration risk classification, foot health and functionality, and foot strength — however, no numerical results were reported for any of these measures on ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03720704 · results posted 16 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 280 people who all received a device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis — a type of small tube (stent graft) placed inside a blood vessel using a minimally invasive procedure. Of the 280 people who started the trial, 210 completed it, while 70 did not complete it (the reasons for non-completion were not reported in the data provided). The trial had one primary outcome measure, which combined two things: whether the procedure was carried out successfully (meaning the device was delivered and put in place correctly, and the vessel was open at the end of the procedure), and whether participants were free from serious problems linked to the device within 30 days. The reported data shows that 274 out of 280 participants met this combined outcome. No secondary outcome measure data was included in the results provided. It is worth noting that the reported data does not break down what happened with the remaining 6 participants, and no further detail about serious adverse events or longer-term outcomes was included in the results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03247972 · results posted 16 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people with peripheral artery disease (a condition where narrowed arteries reduce blood flow to the limbs). The trial was measuring how platelets — the tiny blood cells involved in clotting — behaved after participants took high-dose statin medication for eight weeks, and then again after a further eight weeks of combining that statin therapy with a medicine called evolocumab. The key question was whether adding evolocumab made any difference to how the platelets clumped together (aggregated) or how strong blood clots were. Of the 30 people who started, 26 completed the first eight-week phase, and 24 completed the full trial. The reported data shows the following average differences in platelet measurements between the end of the statin-only period and the end of the combined treatment period. For the main (primary) outcome — platelet clumping triggered by a substance called ADP — the reported average difference was 0.71 percentage points. For the secondary outcomes, platelet clumping triggered by collagen showed an average difference of 1.4 percentage points, while clumping triggered by another substance (SFFLRN) showed a difference of 6.8 percentage points. A measure of platelet activation called P-selectin positive platelets showed a reported difference of 126 percentage points. Finally, a measure of platelet-fibrin clot strength (how firm a blood clot becomes, measured in millimetres) showed an average difference of 1.2 mm. No comparison group data was reported, as this trial followed a single group of participants across two treatment phases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04123093 · results posted 11 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04123093) was testing a product called the Noxsano bandage across two phases. Phase 1 involved healthy volunteers, and Phase 2 involved people receiving wound care. In total, 11 healthy volunteers started Phase 1 (10 completed it, and 1 did not), while 2 wound care participants started Phase 2 (neither completed it). The trial was measuring things like any unwanted reactions or side effects from the bandage, as well as wound size (tracked by measuring the length and width of wounds in centimetres). The reported data shows that in Phase 1, 3 out of the 10 healthy volunteers who completed the phase reported adverse events — that is, unwanted reactions or side effects noted through a questionnaire about tolerance and side effects related to the bandage. For the wound care group, the data was not reported for either the wound surface area measurements or the adverse events questionnaire results, meaning no figures for those outcomes were submitted to ClinicalTrials.gov. It is worth noting that because neither of the 2 wound care participants completed Phase 2, the results from that part of the trial are very limited, and the wound size outcome — which was a primary thing the trial set out to measure — has no reported numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04585763 · results posted 14 August 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people who had calcified (hardened) blockages in the arteries of their legs. The trial tested a device called the Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) system, which uses sound-wave pulses to break up calcium deposits inside blood vessels. The trial measured both safety-related events and how well the procedure opened up the blocked arteries. Of the 37 people who started, 35 completed the study, and 2 did not complete it. The reported data shows that zero out of 37 participants experienced what the trial defined as a "major adverse event" — a category that included things like emergency surgery on the treated leg, major amputation, or serious complications requiring additional treatment. Regarding how well the procedure opened the arteries, 43 lesions (blocked spots) out of the total treated met the trial's definition of "technical success" after the full procedure was complete, meaning the blockage was reduced to 30% or less without a serious tear in the artery wall. When looking at the IVL device step alone (before any additional treatments), 28 lesions met that same standard. Thirty out of 37 participants had all of their treated blockages meet the success definition. Zero participants needed a repeat procedure on the same treated area within the follow-up period. Additionally, 27 out of 35 participants who completed follow-up at 30 days showed an improvement in their leg symptom score (a standard scale used to rate how much leg pain or circulation problems affect daily life) compared to where they started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT04313985 · results posted 1 June 2023
According to the results reported on ClinicalTrials.gov, this trial involved just 4 participants in total — a very small number. It used a "crossover" design, meaning each person received both the real treatment (electrical stimulation applied to a wound) and a sham (inactive/dummy) version of the stimulation, one after the other, each lasting one week, followed by a one-week follow-up period. The trial was looking at several things related to wound care: blood flow through wound tissue, how quickly the wound area changed in size, the level of bacteria in the wound, and how much pain participants reported. The reported data shows that for wound area, the electrical stimulation group had a 31% reduction in wound size, while the sham stimulation group had a 52% reduction in wound size over the same period. For pain (measured on a 0–10 scale, where 0 means no pain and 10 means the worst pain imaginable), the electrical stimulation group scored 0 and the sham stimulation group scored 1. The reported data for the two other measurements — wound tissue blood flow and bacteria levels — was not reported in the submitted results, so no numbers are available for those outcomes. It is worth noting that with only 4 participants, this was an extremely small trial, likely an early-stage pilot study rather than a large-scale investigation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03635190 · results posted 4 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03635190) enrolled 112 participants who had blockages in their leg arteries. The trial was testing a medical device called the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System — a tool designed to clear hardened build-up inside blood vessels. Of the 112 people who started, 103 completed the study. The trial measured both how well the device performed technically and whether participants experienced serious medical events within 30 days. The reported data shows that, for the main technical goal — clearing enough of a blockage without needing any additional treatment — this was recorded across 144 lesions (individual blockages treated). For the main safety measure, 104 participants were reported as free from serious medical events at 30 days. For the secondary outcomes, 143 lesions were recorded as achieving the clinical success definition (less than 50% blockage remaining, with or without extra treatment), and 102 participants met the procedure success definition. The reported data also shows measurements of a leg blood-flow score called the Ankle-Brachial Index (ABI) — a number between 0 and 1 where 1 is normal — recorded as 0.69 at the start, 0.90 at 30 days, and 0.85 at six months. A separate symptom severity score (the Rutherford scale, ranging from 0 to 6 where higher means more severe) was reported as 3.50 at the start, 1.00 at 30 days, and 0.90 at six months. No percentage figures or statistical comparisons were included in the submitted data for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02556931 · results posted 3 November 2022
According to the results reported on ClinicalTrials.gov, this trial involved 117 people who had received a stem cell transplant. They were split into two groups: 57 people in the "Day 90 group" and 60 people in the "Day 60 group." The trial was looking at whether it was possible to stop a medicine called tacrolimus — used after transplants to help prevent a complication called graft-versus-host disease (GVHD), where donated cells can attack the recipient's body — at either 60 or 90 days after the transplant. All participants who started the trial completed it. The reported data shows that in the Day 90 group, 33 out of 57 participants were able to stop taking tacrolimus at the 90-day mark. In the Day 60 group, 42 out of 60 participants were able to stop at the 60-day mark. The trial also tracked whether participants who stopped tacrolimus went on to develop GVHD in the following months. Among those in the Day 90 group who stopped tacrolimus, the reported data shows that 1 person experienced a severe form of acute (short-term) GVHD, and 2 people experienced chronic (longer-term) GVHD serious enough to need extra treatment. In the Day 60 group, 3 people experienced severe acute GVHD and 1 person experienced chronic GVHD requiring extra treatment. These figures describe only the counts of participants in each category as submitted to ClinicalTrials.gov — they do not tell us on their own whether stopping tacrolimus earlier or later is better or worse for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03207451 · results posted 18 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03207451) enrolled 81 people in total across four groups, each receiving a different combination of blood-thinning medicines: vorapaxar alone (21 people), vorapaxar with clopidogrel (8 people), vorapaxar with aspirin (29 people), or vorapaxar with both aspirin and clopidogrel (23 people). The trial was measuring how these medicines affected the way blood cells called platelets clump together (a process called platelet aggregation) and how strongly blood clots formed, after 30 days of treatment. The reported data shows the following results at 30 days. For the main measure of platelet clumping — triggered by a specific chemical called SFLLRN — the maximum clumping recorded was 8% in the vorapaxar-only group, 5% in the vorapaxar-plus-clopidogrel group, 5% in the vorapaxar-plus-aspirin group, and 4% in the group taking all three medicines. For the second main measure — the strength of blood clots formed with thrombin (a natural clotting protein), measured in millimetres using a specialised test — the reported figures were 62.8 mm (vorapaxar only), 61.0 mm (vorapaxar and clopidogrel), 61.6 mm (vorapaxar and aspirin), and 62.2 mm (vorapaxar, aspirin, and clopidogrel). For a secondary measure — the activity level of a protein called von Willebrand factor, which plays a role in clotting — the reported values were 130%, 137%, 132%, and 137% across the four groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01927068 · results posted 15 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled two groups of participants who had a procedure to treat blocked or narrowed leg arteries. The first group, called the Global Cohort, included 370 people, and the second group, called the ISR (In-Stent Restenosis) Cohort — meaning people whose arteries had narrowed again inside a previously placed stent — included 129 people. The trial was measuring whether participants remained free from serious outcomes such as procedure-related death, major amputation of the treated leg, or needing a repeat procedure on the same area, as well as whether the treated artery stayed open (unblocked) over 12 months. The reported data shows that for the primary outcomes in the Global Cohort, 94.8% of participants were free from procedure-related death, major amputation, and needing a repeat procedure at 12 months. In the ISR Cohort, that figure was 84.1%. When looking at whether the treated artery remained open at 12 months (called "primary patency" — meaning no significant re-narrowing was detected on ultrasound and no repeat procedure was needed), the reported data shows 77.8% of lesions in the Global Cohort and 58.8% in the ISR Cohort met this measure. For a secondary outcome looking specifically at freedom from needing a repeat procedure on the treated area at 12 months in the ISR Cohort, the reported figure was 83.5%. It is also worth noting that of the 370 people who started in the Global Cohort, 262 completed the study, while 108 did not complete it; in the ISR Cohort, 121 of 129 completed the study. The reasons participants did not complete the study were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01858363 · results posted 13 October 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01858363) enrolled 294 participants in total — 222 in the paclitaxel-coated balloon group and 72 in the bare (uncoated) balloon group. The trial was looking at a procedure used to open narrowed blood vessels in the leg, comparing a balloon coated with a drug called paclitaxel against a standard balloon with no coating. The study tracked participants over several follow-up visits, with 146 and 46 participants respectively completing the full study period. The reported data shows two main things that were measured. First, the trial looked at whether the treated blood vessel stayed open (called "patency") at 12 months — specifically, whether the vessel had not narrowed again and whether a repeat procedure had not been needed. The reported figure was 83.9% of treated vessels in the coated balloon group and 60.6% in the bare balloon group still meeting that definition at 12 months. Second, the trial measured a combined safety-related outcome — the percentage of participants who were free from procedure-related death within 30 days, and free from major amputation of the treated limb or a repeat procedure on the same spot within 12 months. The reported figures were 94.1% in the coated balloon group and 83.3% in the bare balloon group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02942966 · results posted 28 July 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a device called the Tack Endovascular System (4F), which is used during a procedure to open narrowed or blocked leg arteries. A total of 233 people were enrolled, and 205 of them completed the study. The trial was measuring two main things: whether participants avoided serious limb complications and death in the short term, and how well the treated artery segments remained open over six months. The reported data shows that for the first main measure — tracking how many participants were free from serious limb events (such as amputation above the ankle or a major repeat procedure on the treated artery) over six months, and from procedure-related death within 30 days — 200 out of the participants who were assessed met that outcome. For the second main measure, which looked at how many participants experienced those serious limb events or procedure-related death within 30 days, the reported number was 3 participants. On the secondary measures, the reported data shows that 248 treated artery segments were recorded as remaining open (having blood flow) at six months, and 206 participants were reported as having avoided an above-ankle amputation of the treated leg by six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02928055 · results posted 18 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02928055) looked at a treatment called Peripheral Nerve Stimulation (PNS) for pain. A total of 23 people took part, split across three groups depending on how many hours per day they used the device: 8 people used it for 3 hours a day, 8 for 6 hours a day, and 7 for 9 hours a day. The trial tracked participants from the start of treatment through to a 3-month follow-up, though not everyone completed all stages — by the end of the study, 5, 6, and 5 people remained in each group respectively. The main thing being measured was participants' "worst pain" over the previous 7 days, rated on a scale from 0 (no pain) to 10 (the worst pain imaginable), using a standard pain questionnaire. The reported data shows that at the start of the study, average worst-pain scores across the three groups were 5.6, 6.0, and 5.67 out of 10. At a later time point (the data does not specify exactly when this second measurement was taken), the reported scores were 6.5 for the 3-hours-a-day group, 5.2 for the 6-hours-a-day group, and 4.4 for the 9-hours-a-day group. On this scale, a lower number represents less pain. No figures for the adverse events (side effects) outcome were included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03480685 · results posted 14 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03480685) enrolled 12 participants, and all 12 completed the study — none dropped out. The trial compared two types of heart artery imaging: IVUS (intravascular ultrasound) and OCT (optical coherence tomography). Both are techniques used to look inside blood vessels from the inside. The study measured how well each imaging method could show different features of artery walls — such as the layered structure of the vessel wall, areas of calcium build-up, the appearance of stents (small mesh tubes placed in arteries), and any visual distortions (called "artefacts") in the images. Reviewers scored the images on various rating scales where a lower number means better image quality. The reported data shows that for every image quality category measured, OCT received a score that was equal to or lower than the IVUS score — meaning OCT's images were rated at least as clear as those from IVUS, or clearer. For layered vessel wall structure, IVUS scored 1.61 and OCT scored 1.49 (on a 1–4 scale). For non-layered structure, IVUS scored 2.70 and OCT scored 1.82 (on a 1–5 scale). For calcium visualisation, IVUS scored 2.45 and OCT scored 2.11 (on a 1–5 scale). For stent structure, IVUS scored 1.79 and OCT scored 1.43 (on a 1–3 scale). For image artefacts, IVUS scored 1.87 and OCT scored 1.79 (on a 1–3 scale). Regarding adverse events (unwanted medical occurrences) related to the imaging procedures, the reported data shows zero adverse events were recorded for either imaging method. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03943160 · results posted 3 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03943160) enrolled 50 participants, and all 50 completed the study with no drop-outs. The trial was looking at a procedure called orbital atherectomy — a technique used to treat blockages in heart arteries — when performed through the wrist (known as transradial access) rather than through the groin. The study was measuring how often the procedure could be completed successfully through the wrist without causing serious wrist- or hand-related complications (such as significant bleeding, artery injury, reduced blood flow to the hand, or stroke). The reported data shows that 49 out of 50 participants met the main goal, meaning the procedure was completed through the wrist without any of the defined serious complications. For the secondary measure — which looked at how well the blockage itself was cleared, defined by the amount of narrowing remaining in the artery after the procedure — the reported data also shows that 49 out of 50 participants met that target. No figures were reported for the one participant who did not meet either measure, so the reason is not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02607046 · results posted 15 February 2021
According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants who were each given a different type of physical intervention. One group (22 people at the start) took part in an exercise programme, while the other group (13 people at the start) used a device called NMES — neuromuscular electrical stimulation, which uses mild electrical signals to cause muscles to contract. The trial was measuring mobility, walking ability, and blood flow to the calf muscles. Not everyone finished: 14 people completed the exercise programme and 10 completed the NMES group. The reported data shows the following results at the end of the trial. For the first main measure — a mobility test scored from 0 to 36, where a higher number means better mobility — the exercise group averaged 31.8 and the NMES group averaged 32.3. For the second main measure — how far participants could walk in six minutes — the exercise group averaged 1,295 feet and the NMES group averaged 1,193 feet. For the secondary measure — blood flow (perfusion) to the calf muscle as detected by ultrasound scan, where a higher number indicates more blood flow — the exercise group scored 6.13 and the NMES group scored 4.59. These scores are on a scale with no set upper limit. It is worth noting that the reported data presents end-of-study averages for each group but does not include a direct before-and-after comparison within each group, so the data as reported does not show how much, if at all, participants' scores changed from when they started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02742077 · results posted 4 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study — none dropped out. The trial was looking at a robotic-assisted procedure called pulmonary vein isolation (PVI), which is used in the treatment of an irregular heart rhythm condition. The study used a system called the CorPath 200 to help the doctor perform the procedure, and it measured how well the procedure went technically, as well as tracking radiation exposure for both the patient and the operating doctor. The reported data shows that all 20 participants (100%) met the trial's definition of "clinical success," which meant that the treated blood vessel areas had less than 50% blockage remaining at the end of the procedure. Separately, the reported data shows that zero out of 20 participants experienced a serious problem (called a "serious adverse event") that was linked to the device itself. It is important to note that these figures describe what was recorded during the procedure and are not a broader measure of long-term outcomes. For the secondary measurements, the reported data shows that the average radiation dose received by the operating doctor was 1.9 μSv (microsieverts — a unit used to measure radiation exposure), while the average radiation exposure recorded for patients was 566.7 Gy•m² (a different unit that measures the total radiation delivered during the procedure). No comparison group without the robotic system was included in this data, so the figures are reported as standalone numbers only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01870401 · results posted 12 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01870401) enrolled 287 people in the Lutonix drug-coated balloon (DCB) group and 155 people in the standard balloon angioplasty group. The trial was looking at a procedure used to treat blocked arteries below the knee. It measured two main things: first, whether patients avoided serious complications (such as death, major amputation, or a major repeat procedure on the treated leg) within 30 days; and second, whether patients avoided amputation, a fully blocked treated artery, or a clinically-driven repeat procedure on that artery within 6 months. The reported data shows that for the 30-day safety measure, 284 out of 287 participants in the Lutonix DCB group and 154 out of 155 participants in the standard balloon group were recorded as having avoided those serious complications. For the 6-month measure, 201 out of the DCB group and 88 out of the standard balloon group were recorded as having avoided amputation, full blockage of the treated artery, or a repeat procedure. For secondary measures, the reported data shows that around 61.3% of treated areas in the DCB group and 58.3% in the standard balloon group were considered a technical success at the time of the procedure. Procedural success — meaning at least one artery below the knee was opened adequately — was reported for 84.0% of DCB procedures and 81.4% of standard balloon procedures. A quality-of-life score (rated 0–100, where higher means better) also showed small reported changes from the starting point across both groups at 30 days, 6 months, and 12 months, though the differences between groups were very small. Data for some secondary measures was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02876887 · results posted 6 August 2020
According to the results reported on ClinicalTrials.gov, this trial involved 44 people with peripheral artery disease (a condition where narrowed arteries reduce blood flow to the legs). Participants were randomly assigned to receive either a cocoa drink (23 people) or a placebo drink with no cocoa (21 people) for six months. The trial was mainly measuring whether the cocoa group could walk further in six minutes compared to the placebo group. Nineteen of the 23 cocoa participants completed the study, while all 21 placebo participants completed it. The reported data shows that for the main measure — how far participants could walk in six minutes — the cocoa group's distance increased by an average of 18.4 metres from their starting point, while the placebo group's distance decreased by an average of 24.2 metres. For the secondary measures, the reported data shows mixed results across the groups. On the treadmill walking tests, the placebo group showed slightly higher numbers than the cocoa group (for example, a change of +0.28 minutes for maximum walking time in the placebo group versus -0.03 minutes in the cocoa group). For day-to-day physical activity measured by a wrist device over seven days, the cocoa group showed a smaller decrease in activity counts (-1,919) compared to the placebo group (-8,981). For blood vessel function in the arm, muscle tissue measurements, and blood flow to the calf measured by MRI scan, the reported changes were small in both groups, and the results varied in direction between groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01837069 · results posted 27 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01837069) enrolled 198 people in total — 103 in the treatment group and 95 in the control group. All participants completed the study, with no drop-outs recorded in either group. The trial was measuring whether participants experienced a serious cardiovascular event — specifically death, heart attack, stroke, a brief stroke-like episode (transient ischaemic attack), minor heart muscle damage (myocardial necrosis), or a blood clot in the veins (venous thromboembolism). The reported data shows that, for the primary outcome, 10 out of 103 participants in the treatment group experienced one of these events, compared with 2 out of 95 participants in the control group. For the pre-specified additional measure of length of hospital stay, the reported data shows both groups had a median (middle value) of 3 days. The secondary outcome — a slightly modified version of the same combined event measure that also included reoperation — and the breakdown of each individual event type were listed as outcome measures in the trial, but no numerical results were reported in the submitted data for those measures. It is worth noting that this trial was relatively small, and the reported numbers alone do not tell us whether any difference between the groups was meaningful or due to chance — that would require further context from the full study report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03064126 · results posted 15 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03064126) enrolled a total of 440 participants across four groups. The main group of 278 people received a RANGER™ Paclitaxel Coated Balloon (a type of balloon used to open narrowed leg arteries, coated with a drug called paclitaxel), while 98 people received a standard balloon without any drug coating. A further 52 people took part in a sub-study using a longer version of the balloon, and 12 people took part in a smaller sub-study examining how the drug moved through the body. The trial was primarily measuring whether the treated artery remained open (called "patency") over time, and tracking serious adverse events — meaning death, major limb amputation, or the need to repeat the procedure on the same area. The reported data shows that, for the primary outcome of lesion patency at 12 months, 194 out of the participants in the coated balloon group and 57 out of the participants in the standard balloon group met the criteria for the artery remaining open. In the longer balloon sub-study, 43 participants met the patency criteria at 6 months. For the primary safety measure — tracking how many participants were free from serious adverse events — the reported data shows 241 participants in the coated balloon group, 76 in the standard balloon group, and 50 in the longer balloon sub-study were counted in this assessment. Regarding technical success (meaning the device was delivered and retrieved without problem), this was reported for 277 out of 278 participants in the coated balloon group and 47 out of 52 in the longer balloon sub-study; this figure was not collected for the standard balloon group. The reported data also shows that, looking at serious adverse events across the study period, 15 participants in the coated balloon group and 15 in the standard balloon group experienced at least one such event; in the longer balloon sub-study, 3 participants did. Among those events, 1 death within 30 days was recorded in the coated balloon group and none in the other groups, while no major amputations were reported in any group. The number of participants who needed a repeat procedure on the same area was reported as 14 in the coated balloon group, 15 in the standard balloon group, and 3 in the longer balloon sub-study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01465841 · results posted 7 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 517 participants, all of whom underwent a procedure using PC 400 coils to treat brain aneurysms. Of those who started, 449 completed the study and 68 did not. The trial was measuring several things about the coiling procedure itself: how densely the coils filled the aneurysm, how long patients were exposed to X-ray imaging (called fluoroscopy) during the procedure, serious problems that occurred during the procedure, how completely the aneurysm was blocked off afterwards, and whether any bleeding inside the skull occurred. The reported data shows that, on average, the coils filled about 37.9% of the aneurysm's volume, and the average fluoroscopy (X-ray) time during the procedure was 38.2 minutes. Twelve serious adverse events — meaning significant complications — were recorded as happening during the procedure itself. For the secondary outcomes, the reported data shows that when doctors assessed how well the aneurysm sac was blocked off immediately after the procedure using a standard grading scale (where Grade I is the most complete blockage and Grade III is the least), 214 participants were recorded at Grade I, 136 at Grade II, and 115 at Grade III. Additionally, 4 events of bleeding inside the skull were reported. It is worth noting that this trial had only one group — everyone received the same treatment — so there was no comparison group reported in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01113892 · results posted 22 May 2020
According to the results reported on ClinicalTrials.gov, this trial compared two types of surgical grafts — the EXXCEL Soft and the FUSION Bioline — used to bypass blocked blood vessels in the legs. A total of 101 people were assigned to the EXXCEL Soft group and 106 to the FUSION Bioline group, making 207 participants in all. The trial measured whether the grafts continued to allow blood flow without interruption (called "patency"), how quickly bleeding from stitch holes stopped after the graft was put in, and whether participants experienced serious events such as major amputation, major graft re-operation, or death related to the procedure. The reported data shows that, for the main measure of uninterrupted blood flow (primary patency), 70 out of the EXXCEL Soft participants and 89 out of the FUSION Bioline participants met this measure. For the measure that also allowed minor procedures to keep the graft open (primary assisted patency), the reported numbers were 73 for EXXCEL Soft and 89 for FUSION Bioline. When patency after a procedure to re-open a blocked graft was counted (secondary patency), the reported figures were 80 and 91 respectively. Regarding the serious combined event of major amputation, major graft re-operation, or procedure-related death, the reported data shows 2 participants in the EXXCEL Soft group and 5 in the FUSION Bioline group met this measure at one recorded time point, with some additional figures also reported across different time points. For the time it took for stitch-hole bleeding to stop, the reported median time was 11 minutes for the EXXCEL Soft group and 3.5 minutes for the FUSION Bioline group. It is worth noting that the composite serious-event data in the reported results contained multiple sets of figures that are not fully labelled by time point, so those numbers cannot be described with complete certainty. The data was not reported in a way that allows a straightforward explanation of all those figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01587703 · results posted 16 March 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01587703) tested an investigational drug called GSK525762 in people with certain advanced cancers, including a rare cancer called NMC (nuclear protein in testis midline carcinoma), small cell lung cancer, prostate cancer, triple-negative breast cancer, oestrogen receptor-positive breast cancer, and a stomach/bowel tumour called GIST. The trial was run in two main parts: Part 1 tested different doses of the drug (ranging from 2 mg up to 100 mg, given either once or twice daily) to look at how the body handled the drug at various dose levels, while Part 2 tested the drug in specific cancer types at chosen doses. A separate smaller sub-study also looked at how the drug interacted with two other medicines. In total, across all parts of the trial, the reported data shows that roughly 84 participants took part in Parts 1 and 2 combined, plus 10 participants in the sub-study. The reported data shows that the trial was primarily measuring things like how much of the drug was absorbed into the bloodstream, how long it stayed in the body, and what dose level was considered appropriate to carry forward — these are standard early-phase measurements rather than measures of whether a cancer shrank or grew. For Part 2, the trial also tracked tumour responses across the different cancer groups. The reported numbers for individual blood-level measurements and tumour response rates across each cancer group were submitted to ClinicalTrials.gov, however the full detailed numerical results across all outcome measures were not completely available in the data provided for this summary, so those specific figures cannot be described here without risk of inaccuracy. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03358355 · results posted 12 March 2020
According to the results reported on ClinicalTrials.gov, this trial involved 9 participants, all of whom completed the study with no dropouts. The trial was testing injections of a substance called unacylated ghrelin — a naturally occurring compound in the body — given at three different dose levels (10 micrograms per kilogram of body weight, 20 mcg/kg, and 40 mcg/kg). The main thing being measured was how much unacylated ghrelin appeared in participants' blood before and after each injection. A secondary measurement looked at how well a blood vessel in the arm (the brachial artery) was able to widen in response to increased blood flow — a process called flow-mediated dilation. The reported data shows that before the injections, blood levels of unacylated ghrelin were low across all three dose groups, ranging from about 58 to 71 picograms per millilitre (pg/ml — a very small unit of measurement for substances in the blood). After the injections, those levels rose considerably across all groups. The reported figures at various time points ranged from around 846 pg/ml in the lowest dose group up to approximately 1,999 pg/ml in the middle dose group. For the blood vessel widening measurement, the reported data shows small variations across the three dose groups and two time points, with values ranging from around -2.23 to 1.14 (reported as a ratio). The reported data also notes that in the adverse events tracking (monitoring for any unwanted reactions), zero participants in the 10 mcg/kg and 40 mcg/kg groups recorded adverse events, while 1 participant in the 20 mcg/kg group was recorded as having experienced an adverse event. Additionally, 1 participant across the overall intervention group was recorded as having experienced a serious adverse event, though further detail on this was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02819011 · results posted 27 February 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 44 older adults — 22 in a group that used a special ankle brace called the Moore Balance Brace (MBB), and 22 in a group that did not use the brace. The trial was measuring body sway — that is, how much a person's hips, ankles, and centre of body mass moved while standing — using small wearable sensors. It also looked at how often participants fell, how worried they were about falling, and how many hours a day they wore their prescribed footwear. The study ran over six months, with 15 people completing it in the brace group and 17 in the no-brace group. The reported data shows that, for hip sway, the brace group started at 3.65 units and was recorded at 2.15 units at six months, while the no-brace group went from 3.75 to 3.89 units. For ankle sway, the brace group went from 3.50 to 1.03 units, compared with 3.21 to 3.56 units in the no-brace group. For centre-of-mass sway (measured in square centimetres), the brace group went from 0.71 to 0.32, while the no-brace group went from 0.85 to 0.76. On the falls worry questionnaire — scored from 16 (no concern) to 64 (severe concern) — the brace group started at 32.8 and reached 27.0 at six months, while the no-brace group went from 33.3 to 30.1. The reported data shows that both groups wore their footwear for around 5–6 hours per day on average. Reported fall rates (falls per year) went from 2.27 to 0.80 in the brace group and from 1.82 to 0.94 in the no-brace group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03018223 · results posted 21 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, and all 32 completed the study. The trial was looking at a combined approach involving conditioning treatment, a blood stem cell transplant (known as HCT), and a prevention strategy for a complication called graft-versus-host disease (GVHD) — a condition that can occur after a transplant when donated immune cells attack the recipient's body. The trial was measuring how often this complication occurred, as well as how many participants were still alive and free of their original disease after the transplant. The reported data shows that for the main outcome being tracked — a moderate-to-severe form of acute (short-term) GVHD within the first 100 days after transplant — 18.8% of participants developed this complication. For the secondary outcomes, 20.0% of participants were reported to have developed chronic (longer-term) GVHD within one year. When it came to overall survival — meaning the percentage of participants still alive at the point of follow-up — the reported figure was 70.2%. The reported data also shows that 56.6% of participants were alive and free of disease progression one year after their transplant. It is worth noting that this trial had only one group, meaning everyone received the same treatment and there was no comparison group, so these figures describe that single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01680835 · results posted 26 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01680835) enrolled 108 participants, all placed in a single study group. The trial was measuring outcomes related to a vascular procedure — specifically, it tracked whether participants remained free from three events over time: death shortly after the procedure, major amputation of the treated limb, and the need for a repeat procedure to re-open the treated blood vessel (called "target lesion revascularisation"). These three things were combined into a single main measure, and results were also tracked separately at one, two, and three years. The reported data shows that, of the 108 people who started the trial, 83 completed it and 25 did not. For the main combined measure (freedom from early death, amputation, and repeat procedure), the reported numbers of participants meeting that combined goal were 15, 23, and 24 at the three follow-up time points respectively, though the trial data does not clearly label which number corresponds to which year. For the secondary measures: the number of participants reported as free from a major amputation showed 0, 1, and 1 participants experiencing an amputation across the follow-up periods (meaning very few amputations were recorded, but the data as submitted does not specify exact timepoints for each figure). The number free from a repeat procedure on the treated vessel was reported as 15, 22, and 23 participants at the tracked time points. All 108 participants were reported as free from death within 30 days of the procedure. For stent fractures (breaks in the small mesh tube placed in the vessel, checked by X-ray), the reported data shows 0, 1, and 3 stents with fractures recorded across the follow-up periods. It is worth noting that the data as submitted to ClinicalTrials.gov does not clearly label every time point for each measure, so some figures above cannot be precisely matched to a specific year. Where information was not clearly reported, this summary has not filled in the gaps. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01146834 · results posted 17 December 2019
According to the results reported on ClinicalTrials.gov, this trial looked at different drug combinations used to help collect stem cells from patients — likely those being treated for a blood-related condition — before a stem cell transplant. The trial originally planned five groups (Arms A through E), but no patients were enrolled in Arms D or E. In total, 47 patients started the study: 20 in Arm A (bortezomib, cyclophosphamide, and G-CSF), 4 in Arm B (bortezomib and G-CSF), and 23 in Arm C (cyclophosphamide and G-CSF). Of these, 17, 4, and 21 patients respectively completed the study. The reported data shows that the main thing being measured was how many patients in each group could collect a specific target amount of stem cells (at least 6 million CD34+ cells per kilogram of body weight) within two collection sessions. According to the results, 11 out of 20 patients in Arm A and 14 out of 23 patients in Arm C reached this target. In Arm B, none of the 4 patients reached this collection target. No data was reported for Arms D and E, as no patients were enrolled in those groups. The reported data also shows two secondary measurements, both looking at recovery after a subsequent transplant procedure. For recovery of infection-fighting white blood cells (neutrophils) within 20 days: 7 patients in Arm A, 4 in Arm B, and 11 in Arm C were reported to have achieved this. For recovery of platelets (cells that help blood clot) within 20 days: 4 patients in Arm A, 1 in Arm B, and 9 in Arm C were reported to have achieved this. No figures were reported for Arms D and E. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01251575 · results posted 9 December 2019
According to the results reported on ClinicalTrials.gov, 77 people took part in this single-group trial, which involved a stem cell transplant procedure combined with a drug called fludarabine and medications to suppress the immune system. Seventy-six participants completed the study, and one did not. The trial was primarily looking at how many participants developed a condition called acute graft-versus-host disease (GVHD) — this is where donated cells can attack the recipient's body after a transplant. Participants were divided into two subgroups based on a type of tissue-matching difference between donor and recipient (called Class I or Class II mismatch). The reported data shows that, for the primary outcome, 15 out of the participants in the Class I mismatch subgroup and 12 out of the participants in the Class II mismatch subgroup developed moderate-to-severe acute GVHD (recorded as Grade II–IV). The reported data also shows that, looking at only the most severe forms (Grade III–IV acute GVHD), 2 participants across the whole group were recorded as reaching that level. As a secondary outcome, 3 participants were reported to have died without their underlying disease coming back or progressing — a figure the trial recorded separately from disease-related deaths. It is worth noting that the data as submitted does not break down the total number of participants per subgroup, so it is not possible from this report alone to calculate the proportion affected in each subgroup. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01961167 · results posted 6 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01961167) enrolled 27 participants, all of whom completed the study. The trial was looking at a device called the Gore VIABAHN BX stent, used in a procedure to treat a narrowed or blocked artery in the iliac region (the large arteries in the pelvis area). The main thing the trial was measuring was whether participants experienced any serious adverse events — specifically, death related to the device or procedure within 30 days, a heart attack within 30 days, or an amputation above the foot in the treated leg within 30 days. The reported data shows that for the primary outcome — that combination of serious events — the result was 0%, meaning none of the 27 participants were reported to have experienced any of those events. For the secondary outcomes, the reported data shows that all 27 participants were recorded as having achieved what the trial called "acute procedural success," meaning the procedure met a defined technical standard and no serious device- or procedure-related problems were recorded before discharge. At the 30-day follow-up, 25 out of 27 participants were reported to have met the criteria for "30-day clinical success," which included showing at least some improvement in their leg symptoms compared to before the procedure, with no serious related adverse events in that period. The reported data also shows that blood flow through the treated artery segment — measured without any need for a repeat procedure — was reported at 100% of treated vessels at both the 30-day and 6-month follow-up points. It is worth noting that this was a small study of 27 people and the results cover only up to six months of follow-up, so the reported figures reflect a limited timeframe and a specific group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02094755 · results posted 28 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people, all of whom completed the study (no one dropped out). All participants had a condition called critical limb ischaemia — a severe reduction in blood flow to the legs — and were already being treated with two blood-thinning medications, aspirin and clopidogrel. The trial was measuring how many of these patients had platelets (tiny blood cells involved in clotting) that were not being sufficiently suppressed by their medication, a situation sometimes called "high on-treatment platelet reactivity." The reported data shows that platelet response was measured using three different laboratory tests. One test measured the response to aspirin and found that 18 out of 100 participants showed insufficient platelet suppression from that medication. Two separate tests measured the response to clopidogrel: one of these tests found that 17 out of 100 participants showed insufficient suppression, while the other found that 8 out of 100 did. A fourth measurement was also reported — 57 participants — though the data as submitted does not clearly label which specific test or category this figure corresponds to, so a plain description of what it represents cannot be provided without risk of misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02655887 · results posted 12 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 170 people who received a VENOVO™ venous stent — a small mesh tube placed inside a vein to help keep it open. The trial was measuring two main things at the same time: how many participants still had their stent working well (without blockage or significant narrowing) at 12 months, and how many were free from serious complications. A secondary focus was on whether participants' symptoms and quality of life changed over time. Of the 170 who started, 156 completed the study and 14 did not. The reported data shows that 128 out of 170 participants had their stent recorded as still open and unblocked at 12 months (meaning no repeat procedure was needed, and scans showed less than 50% narrowing). For the safety measure, 159 out of 170 participants were recorded as free from the list of serious adverse events (unwanted medical events) defined by the trial. The reported data also shows changes in symptom and quality-of-life scores from the start of the trial to the 12-month mark: a clinical severity score (rated 0–30, where lower is better) dropped by an average of 1.7 points, and a quality-of-life questionnaire score (rated 20–100, where lower is better) dropped by an average of 15.7 points. A separate vein disease classification score also showed small reductions at 30 days, 6 months, and 12 months of −1.1, −1.3, and −1.5 points respectively. All 170 participants had the stent successfully placed at the time of the procedure, according to the investigators. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01008462 · results posted 29 May 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom completed the study. The trial was investigating a two-step stem cell transplant approach for patients with a type of blood cancer called chronic lymphocytic leukaemia (CLL). The approach involved first receiving a transplant using the patient's own stem cells (autologous), followed by a transplant using a donor's stem cells (donor HCT). The trial was measuring how many participants survived without their disease returning or getting worse, as well as a range of other outcomes including overall survival, disease relapse, and transplant-related complications. The reported data shows that out of 16 participants, 9 were recorded as surviving without their disease relapsing or progressing (the primary outcome). In terms of other reported results, 10 participants were recorded as surviving one year after the first (autologous) transplant, and 6 participants experienced relapsed or progressive disease. The reported data shows that 13 participants successfully received the donor cells (engraftment). Regarding a complication called graft-versus-host disease — where donated cells can react against the recipient's body — 8 participants were reported to have experienced a moderate-to-severe acute form, and 1 participant was reported to have experienced an extensive chronic form. For deaths not related to the disease returning, the reported data shows 0 occurred after the first transplant and 1 occurred after the donor transplant. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01159067 · results posted 29 May 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01159067) enrolled just one participant in a single treatment group called "Arm I." That one participant completed the study without dropping out. The trial was looking at levels of two substances in the blood — something called Labile Plasma Iron (LPI), which is a form of iron that circulates freely in the blood, and Serum Ferritin, which is a protein that reflects how much iron is stored in the body. The study was trying to track whether these levels changed over the course of treatment. The reported data shows that for the primary outcome — the number of participants whose LPI level was above a set threshold of 0.5 µmol/L (micromoles per litre, a standard unit of measurement) — the result was zero out of one participant. In other words, the single participant's LPI was not above that threshold. For the secondary outcomes, the reported data shows that one out of one participant had a Serum Ferritin level below 1,500 ng/mL (nanograms per millilitre) at two consecutive visits during the study. The other two secondary outcomes — whether LPI dropped below the threshold after treatment, and any relationship between LPI and Serum Ferritin levels — were not reported in the submitted data. It is worth noting that with only one participant, this trial was extremely small, and the numbers above reflect the experience of that single individual only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03312348 · results posted 24 April 2019
According to the results reported on ClinicalTrials.gov, this trial involved 30 children who presented with a limp. The study was looking at whether a thermal (infrared) imaging technique — a type of camera that detects heat differences in the body — could correctly identify the area of the body that was the focus of concern in each child. All 30 participants who started the trial completed it. The reported data shows that the primary outcome measured was the number of children for whom the thermal imaging correctly identified the area of focus. According to the results submitted, thermal imaging correctly identified the area of focus in 30 out of 30 participants. It is worth noting that the description field in the submitted data includes a reference to the number "25," though the measured result recorded is 30 — the trial registry does not provide a clear explanation for this discrepancy, so this detail cannot be clarified from the available data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02716805 · results posted 26 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02716805) enrolled 6 people in Cohort 1, which was the only group to recruit any participants — Cohorts 2, 3, and 4 each had zero participants. Of the 6 who started, 4 completed the study and 2 did not. The trial was measuring side effects (called adverse events) that occurred during treatment with the immunotherapy drugs tremelimumab and durvalumab given around the time of a stem cell transplant, as well as how participants' blood cancer (multiple myeloma) responded to treatment. The reported data shows that all 6 participants in Cohort 1 experienced at least one treatment-emergent adverse event — that is, an unwanted health event that occurred during the study period. Of those, 2 participants experienced what the trial defined as a dose-limiting toxicity (a serious side effect serious enough to potentially limit the dose used). The reported data also shows various other adverse event categories were recorded across the 6 participants, with individual counts of 4, 1, 5, 1, 1, 0, and 0 for different event types, though the specific labels for each of these sub-categories were not separately identified in the data provided to ClinicalTrials.gov. For the secondary outcome — how the cancer responded to treatment — the reported data shows that of the participants assessed, 1 achieved a stringent complete response (meaning no detectable cancer signs by strict criteria), 2 achieved a very good partial response (meaning a large reduction in cancer markers), and 1 achieved a partial response (meaning a meaningful but smaller reduction in cancer markers). Response data was not reported for the remaining participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01609296 · results posted 28 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,406 participants in total, all placed in a single group called the "Clinical Cohort ITT" (meaning all participants who were intended to be treated). Of those, 918 completed the study and 488 did not finish. The trial was measuring how well a drug-eluting balloon (a type of medical device used to open narrowed blood vessels in the leg) performed over 12 months. It tracked two main things: whether patients needed a repeat procedure on the treated area of the vessel (called target lesion revascularisation, or TLR), and whether serious complications — such as death related to the device, major limb amputation, or needing a repeat procedure — occurred. The reported data shows that for the primary effectiveness measure — counting participants who did *not* need a clinically driven repeat procedure on the treated vessel within 12 months — the number reported was 1,263. For the primary safety measure — counting participants who were free from device- or procedure-related death within 30 days, major limb amputation, and repeat procedures within 12 months — the number reported was 1,254. A smaller sub-group of 217 participants also had imaging tests to check whether the vessel stayed open (called "primary patency"), and a further sub-group of 106 participants who received a specific 150 mm device length also had their freedom from repeat procedures reported. The reported data also shows that 161 participants experienced a major adverse event (a serious complication such as death from any cause, a repeat procedure on the broader vessel, major amputation, or a blood clot at the treatment site), and 101 participants underwent any form of repeat procedure on the treated area. It is worth noting that the results as submitted report participant counts rather than percentages or comparison figures against a control group, so the data as provided does not include a direct before-and-after or treated-versus-untreated comparison. Some additional detail that might ordinarily accompany these numbers — such as percentage rates — was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02374957 · results posted 23 November 2018
According to the results reported on ClinicalTrials.gov, this was a small pilot trial involving 20 people who had recently undergone a procedure to restore blood flow in a leg artery. Eleven participants were given a medication called cilostazol, and nine were in a control group (not given the medication). The trial was measuring quality of life — how people felt about their health and ability to move around — at six weeks and three months after their procedure. The goal of this pilot was mainly to gather enough information to plan a larger trial in the future, not to reach a definitive conclusion. The reported data shows that quality of life was tracked using two questionnaires. The first (called the EQ-5D sum score) rates health across five areas like mobility and pain, on a scale of 5 to 25 where **lower scores mean a better health state**. At the start, the cilostazol group averaged 14.00 and the control group averaged 15.57. By six weeks, both groups had similar scores (12.89 vs 12.14), and by three months they were again similar (13.75 vs 12.50). The second part of the same questionnaire asked people to rate their overall health on a scale of 0 to 100, where **higher is better**. At six weeks, the cilostazol group averaged 60.00 and the control group 71.43; at three months, the cilostazol group averaged 47.50 and the control group 65.83. A separate walking-ability questionnaire (scored 0–100, higher is better) showed both groups scoring in the low-to-mid teens at all time points, with only small differences between groups reported at six weeks and three months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02653456 · results posted 24 October 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people who were treated using a combination of two devices — the RA-308 Excimer Laser and the DABRA Catheter — which are tools used during procedures to open up blocked blood vessels. There was only one group in this trial, meaning all participants received the same treatment; there was no comparison group. Of the 64 people who started, 59 completed the trial and 5 did not finish. The trial was primarily measuring whether these devices could successfully cross (pass through) a blocked section of a blood vessel, as confirmed by imaging of the blood vessel. The reported data shows that 60 out of 64 participants had the device successfully cross the target blockage in their blood vessel, as measured by imaging analysis. For the secondary outcomes — which looked at additional things the researchers were tracking — the reported data shows that 0 participants experienced what the researchers defined as a device-related major adverse event, and 0 participants required a repeat procedure on the same blocked vessel (called "target lesion revascularisation"), meaning no additional procedures of that type were recorded during the follow-up period. It is worth noting that one secondary outcome appears to have been listed twice in the submitted data with identical results. It is important to understand that this trial had no comparison group, so the numbers above only describe what happened in people who received this particular combination of devices. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01776424 · results posted 5 October 2018
According to the results reported on ClinicalTrials.gov, this trial (known as COMPASS) enrolled over 27,000 people across three groups. Each group took a different combination of two blood-thinning medicines — rivaroxaban and aspirin — or a dummy pill (placebo) in place of one of them. The three groups were: rivaroxaban 2.5mg plus aspirin 100mg (about 9,152 people); rivaroxaban 5mg plus aspirin placebo (about 9,117 people); and rivaroxaban placebo plus aspirin 100mg (about 9,126 people). The trial was measuring how often people in each group experienced a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) cause, and also how often serious bleeding occurred. The reported data shows that for the main "cardiovascular events" outcome — counting the number of participants who had a heart attack, stroke, or cardiovascular death — 379 people in the rivaroxaban 2.5mg plus aspirin group experienced one of these events, compared with 448 in the rivaroxaban 5mg alone group, and 496 in the aspirin-only group. For the serious bleeding outcome, the reported numbers were 288 in the rivaroxaban 2.5mg plus aspirin group, 255 in the rivaroxaban 5mg group, and 170 in the aspirin-only group. These are simply counts of how many people in each group reached each measured event — the trial also calculated hazard ratios (a way of comparing the timing and rate of events between groups), but those figures were not included in the structured data submitted. The reported data shows similar patterns across the secondary outcomes. For example, deaths from any cause were reported as 313 in the rivaroxaban 2.5mg plus aspirin group, 366 in the rivaroxaban 5mg group, and 378 in the aspirin-only group. A smaller, follow-on open-label extension phase also took place, in which participants could continue on rivaroxaban 2.5mg plus aspirin; among those roughly 4,399 people who entered that phase, 353 experienced a primary cardiovascular event during it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01901224 · results posted 24 September 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01901224) enrolled 2 participants in total. The study was designed to look at whether metformin (a medication) or a placebo (a dummy treatment) over 12 weeks would affect several measures related to leg muscle function and blood vessel health in participants. The main thing being measured was how quickly a molecule called phosphocreatine — which helps muscles produce energy — recovers after exercise, as a way of gauging how well the muscles' energy-producing processes are working. Secondary and additional measures included how well blood vessels could widen in response to blood flow, how long participants could walk on a treadmill (both without pain and at maximum effort), oxygen use during exercise, and distance covered in a six-minute walk test. The reported data shows that neither of the 2 participants who started the trial completed it, meaning both withdrew or were unable to finish. Because no participants completed the study, no results were recorded for any of the outcome measures — not for the primary measure of muscle energy recovery, nor for any of the secondary or additional measures such as blood vessel function or walking tests. The data was simply not reported for any of these outcomes, as the trial ended without any completions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02143102 · results posted 6 August 2018
According to the results reported on ClinicalTrials.gov, this trial involved 125 people in total, split into two groups: a "Development Set" of 97 participants and a "Testing Set" of 28 participants. The trial was testing a software tool called vascuCAP™, which analyses medical scans to measure two things inside blood vessel walls — areas of calcification (calcium build-up) and areas called lipid-rich necrotic core (fatty, dead tissue). The goal was to see how closely the software's measurements matched measurements taken directly from tissue samples examined under a microscope (called histopathology), which was used as the reference standard. Of the 97 people in the Development Set, 86 completed the study, while 11 did not complete it; all 28 in the Testing Set completed the study. The reported data shows the results in terms of "bias," which simply means the average difference between what the software measured and what the tissue examination found — a smaller difference means the two methods gave more similar results. For calcification, the reported bias was −0.47 mm² in the Testing Set and 0.07 mm² across the full group. For the lipid-rich necrotic core, the reported bias was 1.26 mm² in the Testing Set and 0.87 mm² across the full group. These figures represent how far off, on average, the software's measurements were from the tissue-based measurements, in either direction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02080871 · results posted 17 July 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 134 participants who received a device called the Gore VIABAHN BX, a type of stent (a small tube used to prop open a narrowed blood vessel) placed in an artery in the pelvis area (the iliac artery). Of the 134 people who started the trial, 132 completed it and 2 did not. The trial was primarily measuring how many participants experienced a "major adverse event" — defined as a serious problem such as death related to the device or procedure within 30 days, a heart attack within 30 days, a repeat procedure on the treated blood vessel within 9 months, or a major amputation of the treated limb within 9 months. The reported data shows that 2.3% of participants experienced one of these major adverse events during the study period. For the secondary measures, 130 out of 134 participants were reported to have had an immediately successful procedure (meaning the artery was sufficiently opened and there were no serious device- or procedure-related complications before leaving hospital). At 30 days, 108 participants were reported to have shown an improvement of at least one step on a scale used to measure leg circulation symptoms (called the Rutherford Category), with no serious related complications in that timeframe. The reported data also includes estimates of "primary patency" — a measure of how many participants' treated vessels remained open without needing an additional procedure. At 30 days, this figure was reported as 99.2%, and at 9 months it was reported as 96.7%. A related measure called "primary assisted patency" at 30 days (which also counts vessels kept open with the help of an additional procedure) was also reported as 99.2%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00593385 · results posted 17 May 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 165 people in total, with 152 included in the main analysis group (called the "intention to treat" population — meaning everyone who was enrolled and intended to be treated). The trial involved a single covered stent device called the ICAST, used in blood vessel procedures. The study was measuring a combination of outcomes over nine months: whether participants died within 30 days of the procedure, needed a repeat procedure on the treated area within nine months, or had a significant re-narrowing of the treated vessel at nine months (checked by ultrasound). The reported data shows that 8.1% of the main analysis group experienced at least one of those combined outcomes (death within 30 days, repeat procedure, or re-narrowing) by the nine-month mark. For the secondary measures, the reported data shows that 150 out of 152 participants had the stent successfully delivered and the device retrieved intact. A total of 140 participants achieved what the trial called "acute procedural success" — meaning the artery was left with less than 30% blockage immediately after stent placement and without a serious in-hospital vascular event. Eight participants experienced a major adverse event (a combined count of serious vascular events, any death, or stroke), and seven participants experienced a major adverse vascular event (a grouped measure covering things like heart attack, stent blockage, limb-related complications, or a bleeding event needing a blood transfusion). The data also shows a separate figure of 10 participants for this same major adverse vascular event measure — though the data as reported does not clearly explain the difference between these two figures for that outcome. It is worth noting that 40 participants did not complete the study, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02246660 · results posted 30 April 2018
According to the results reported on ClinicalTrials.gov, this trial involved 66 people with Peripheral Artery Disease (a condition where narrowed arteries reduce blood flow to the limbs). Participants were divided into three groups: 23 people took a higher dose of resveratrol (500 mg per day), 21 took a lower dose (125 mg per day), and 22 took a placebo (a dummy pill with no active ingredient). The trial ran for six months and was measuring changes in how far participants could walk in six minutes — a common way of assessing physical ability in people with this condition. The reported data shows that, after six months, the average change in six-minute walking distance was as follows: the higher-dose resveratrol group (500 mg) walked an average of 12.8 metres *less* than at the start; the lower-dose group (125 mg) walked an average of 4.6 metres *more* than at the start; and the placebo group walked an average of 12.3 metres *less* than at the start. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so the reported data shows only these figures. It is worth noting that the trial did not report any additional breakdown of these numbers — for example, no information about whether the differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance) was included in the submitted data. If that information exists, it was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01858428 · results posted 17 January 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 300 people in total — 100 received a standard balloon procedure (called "Bare PTA") and 200 received a drug-coated balloon procedure ("Drug-Coated PTA"). The trial was looking at a procedure used to open up narrowed or blocked leg arteries. It measured two main things: whether the treated artery stayed open at 12 months (called "patency"), and whether patients were free from serious events such as procedure-related death, major amputation of the treated leg, or needing a repeat procedure on the same spot within 12 months. The reported data shows that for the primary measure of the artery staying open at 12 months, 53 out of 100 participants in the Bare PTA group and 135 out of 200 in the Drug-Coated PTA group met this measure. For the second primary measure — being free from the combination of serious events (procedure-related death, major amputation, or repeat procedure) — 79 out of 100 participants in the Bare PTA group and 174 out of 200 in the Drug-Coated PTA group met this measure. The reported data also shows that for secondary measures, major adverse events (a combined count of cardiovascular death, major amputation, and repeat procedures) were recorded in 17 events in the Bare PTA group and 18 events in the Drug-Coated PTA group. Vascular access or bleeding complications were recorded in 3 participants (Bare PTA) and 8 participants (Drug-Coated PTA). Clinically-driven repeat procedures on the same spot were needed by 15 participants (Bare PTA) and 16 participants (Drug-Coated PTA), and the broader measure of any repeat procedure on the same spot was recorded in 17 (Bare PTA) and 18 (Drug-Coated PTA) participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01802775 · results posted 12 January 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01802775) enrolled 203 people in total — 102 in the clopidogrel group and 101 in the edoxaban group. Both clopidogrel and edoxaban are blood-thinning medicines. The trial was measuring two main things: how often participants experienced a clinically meaningful bleed (that is, a serious or notable bleed) during treatment, and how often a treated blood vessel became narrowed or blocked again within six months. Participants were followed for up to six months. The reported data shows that for the primary measure of clinically relevant bleeding, 8% of participants in the clopidogrel group and 11% in the edoxaban group experienced this over the full study period; at an earlier three-month point, both groups showed 6%. For the re-narrowing or re-blocking of blood vessels, the reported figures were 34.7% in the clopidogrel group and 30.9% in the edoxaban group. On secondary measures, serious unwanted medical events (called serious adverse events) were recorded in 30 people in the clopidogrel group and 31 in the edoxaban group. Major heart or stroke-related events (such as heart attack, stroke, or cardiovascular death combined) were reported in 1 person in the clopidogrel group and 3 in the edoxaban group. Amputations within six months were reported for 3 people in the clopidogrel group and 1 in the edoxaban group. Some of the secondary bleeding sub-category figures appear in the data, but the data as submitted does not clearly label each individual sub-category number, so a full breakdown cannot be provided here without risk of misrepresenting the figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00858130 · results posted 29 November 2017
According to the results reported on ClinicalTrials.gov, this trial involved 12 participants, all of whom completed the study with no drop-outs. The trial was looking at a device called VeinoPlus, which uses mild electrical stimulation through pads placed on the skin of the leg to cause muscle contractions. The study was measuring things like the intensity level participants chose to use the device at, whether participants felt their symptoms improved, and whether scores on standard questionnaires about leg condition and quality of life changed between the start and end of the study. The reported data shows that the middle (median) intensity level that participants chose for the greatest benefit was 32 out of a possible range of 0 to 50. When it came to what the researchers called "clinical success" — meaning a participant reported at least moderate improvement and wanted to keep using the device — 7 out of 12 participants met this definition. The reported data also shows that 8 out of 12 participants had an improvement in their leg condition score (measured using a standard scale called the Villalta score, which rates symptoms like cramps and pain). For quality of life, 10 out of 12 participants showed an improvement on one questionnaire measure, and 9 out of 12 showed an improvement on a related measure focused specifically on venous (leg vein) symptoms. It is worth noting that this was a very small study with only 12 participants and no comparison group, which limits what can be concluded from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01029912 · results posted 6 November 2017
According to the results reported on ClinicalTrials.gov, this trial involved 26 people in total — 14 in one group (called CCNMES) and 12 in another group (called Cyclic NMES). Both groups received a form of neuromuscular electrical stimulation, which is a technique that uses gentle electrical pulses to activate muscles in the leg. The trial ran for six weeks and was measuring changes in three things: leg movement ability (using a scoring tool called the Lower Extremity Fugl-Meyer), walking speed, and how long it took participants to complete a set of everyday walking tasks. Of the 26 who started, 24 completed the trial — 12 from each group, with 2 people in the CCNMES group not finishing. The reported data shows the following changes from the start of treatment to the end of the six weeks. For the leg movement score (which goes from 0 to 34, where higher is considered better), the CCNMES group's scores changed by an average of 0.93 points, while the Cyclic NMES group's scores changed by an average of 1.8 points. For walking speed, the CCNMES group showed an average increase of 3.0 centimetres per second, compared to 1.2 centimetres per second in the Cyclic NMES group. For the timed walking task (where a lower time is considered better), the CCNMES group's completion time changed by an average of minus 9.6 seconds and the Cyclic NMES group's by an average of minus 3.2 seconds — meaning both groups took less time on average at the end of treatment than at the start. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00054353 · results posted 16 October 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total — 12 who received a stem cell transplant from a related donor (such as a family member) and 4 who received one from an unrelated donor. The trial was studying what happened to these participants after a type of stem cell transplant used to treat multiple myeloma. It tracked several things, including how long participants went without their disease getting worse, whether the transplanted cells successfully "took hold" in the body, deaths not caused by the disease returning, and the occurrence of a complication called graft-versus-host disease (GVHD) — where the donated cells attack the recipient's body. The reported data shows that, among the 12 participants in the related-donor group, 4 experienced their disease progressing or returning (a measure called progression-free survival), 1 died from a cause other than the disease coming back, 2 developed a severe form of acute GVHD, and 4 developed a longer-lasting extensive form of GVHD. All 12 participants in this group had their transplanted cells successfully engraft. In the unrelated-donor group of 4 participants, 1 experienced disease progression, 1 died from a non-relapse cause, no one developed severe acute GVHD, and 1 developed extensive chronic GVHD. All 4 participants in this group also had successful engraftment. For overall survival over time, the reported data shows numbers of surviving participants declining across multiple follow-up points in the related-donor group (from 8 down to 3), while in the unrelated-donor group the numbers declined from 3 to 0 — though the specific time points for these figures were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00346164 · results posted 6 October 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 588 people in total across four treatment groups. The groups were: those who received no additional treatment after surgery (Arm A, 222 people); those considered low risk who received radiotherapy after surgery (Arm B, 21 people); those considered intermediate or high risk who received chemotherapy combined with radiotherapy after surgery (Arm C, 122 people); and those considered intermediate or high risk who received chemotherapy combined with radiotherapy before surgery (Arm D, 223 people). The trial's main goal was to measure "event-free survival" — that is, how likely participants were to go five years without their cancer returning, developing a new cancer, or dying. The reported data shows the following five-year event-free survival probabilities for each group: Arm A (no additional treatment) had a probability of approximately 0.90, meaning roughly 90 in every 100 participants in that group reached five years without one of those events; Arm B (radiotherapy after surgery) had a probability of approximately 0.76; Arm C (chemoradiotherapy after surgery) had approximately 0.61; and Arm D (chemoradiotherapy before surgery) had approximately 0.49. For Arm D specifically, the reported data also shows that about 33% of participants had their tumour shrink (either completely or partially) before surgery, the average level of tumour tissue that had broken down (necrosis) was reported as 59.4%, and approximately 3% of Arm D participants experienced a severe (grade 4 or higher) unwanted side effect. The reported data also shows differences based on whether the cancer had spread: those without spread had a five-year event-free survival probability of about 0.78, compared with about 0.20 for those whose cancer had spread to other parts of the body. Additionally, the reported data shows differences based on how the tumour cells looked under a microscope (histologic grade — a measure of how abnormal the cells appeared). Grade 1 (least abnormal) had a probability of approximately 0.96, Grade 2 had approximately 0.85, and Grade 3 (most abnormal) had approximately 0.61. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01938391 · results posted 18 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom used a device called the Stealth 360°® Orbital Atherectomy System (OAS) — a tool used during a procedure to treat narrowed arteries in the leg. The trial was measuring several things: how often participants needed a repeat procedure on the same artery section (called target lesion revascularisation, or TLR), the pressure needed to inflate a balloon during the procedure, whether any complications occurred during the procedure, and how participants' leg blood flow and symptoms changed over time. All 25 participants completed the early stages of the trial, with 22 finishing the 12-month follow-up. The reported data shows that the estimated probability of needing a repeat procedure on the treated artery was 4.0% at 6 months and 8.2% at 12 months. The average maximum balloon inflation pressure recorded was 5.2 atm (a unit of pressure). Regarding procedural complications, the reported data shows that 4 participants experienced something called "distal embolisation" (where small material moves downstream in the artery), while no participants were reported to have the other tracked complications. In terms of blood flow, a measurement called the ankle-brachial index — a ratio comparing blood pressure at the ankle versus the upper arm, where a normal range is roughly 0.9 to 1.2 — was reported as 0.74 at the start of the trial (below normal), rising to 1.01 at two weeks, 0.96 at six months, and 0.95 at twelve months. Regarding symptom severity, most participants (24 out of 25) were in the mild-to-severe leg pain category at the start; by 12 months, the distribution across severity categories had shifted, though the full breakdown across all time points was not straightforward to interpret from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02227368 · results posted 14 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total — 16 in the ticagrelor group and 24 in the aspirin group. The trial was comparing these two blood-thinning medications in people with a condition that causes leg pain during walking (known as peripheral artery disease). The main thing being measured was how long participants could walk before pain became too much (called "peak walking time"), and a secondary measure looked at how long it took before the walking-related leg pain first appeared ("claudication onset time"). Of those who started, 10 out of 16 in the ticagrelor group and 17 out of 24 in the aspirin group completed the full treatment period, with 14 and 20 respectively completing the overall study. The reported data shows that, for the main measure — change in peak walking time from the start of the trial to week 26 — the ticagrelor group recorded a change of 0.0 log(seconds) and the aspirin group recorded a change of 0.1 log(seconds). In plain terms, these numbers represent how much walking time changed over the course of the trial on a mathematical scale used to handle wide variation in times; a value closer to zero means little change from the starting point. For the secondary measure — when leg pain first started during walking — the reported data shows a change of 0.6 log(seconds) in the ticagrelor group and 0.5 log(seconds) in the aspirin group. It is worth noting that the trial was relatively small, with only 40 participants across both groups, and the data as submitted does not include additional statistical detail (such as measures of uncertainty or comparison between groups) that would normally help interpret what these numbers mean more fully. That information was not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01444378 · results posted 6 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 141 people who received a leg artery stent (a small tube inserted to hold a narrowed or blocked blood vessel open) using one of two related devices — the Absolute Pro® or Pro LL® Peripheral Stent Systems. Of those 141 participants, 124 completed the study and 17 did not. The trial was measuring two main things: whether serious, harmful events occurred after the procedure, and whether the treated blood vessel remained open (unblocked) over time. The reported data shows that for the primary safety measure — which tracked a combination of death from any cause, major amputation of the treated leg, or the need to redo the procedure on the same spot — the reported figure was 0.0% at each time point recorded, meaning none of these events were counted in the data as submitted. For the primary vessel-openness measure taken at a longer follow-up point, the reported figure was 60.8% of participants, meaning roughly six in ten still had an open, unblocked vessel at that stage according to the measurement method used. An earlier vessel-openness measure, reported as a secondary outcome, showed 100% of participants. For the procedure itself, the reported data shows that 96.6% of devices were successfully placed and removed as intended, 97.1% of participants had the artery narrowing reduced to an acceptable level shortly after the procedure, and 97.1% of treated spots met the combined technical definition of success. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01110135 · results posted 24 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 participants, all of whom received a combination of chemotherapy and a colony-stimulating factor (a type of medication that encourages the body to produce blood stem cells). The trial was measuring how well this treatment combination could mobilise and collect peripheral blood stem cells (PBSCs) — that is, stem cells that move from the bone marrow into the bloodstream, where they can be collected for later medical use. 34 of the 43 participants completed the study, while 9 did not complete it (the reasons were not detailed in the reported data). The main thing being measured was whether enough stem cells could be successfully collected from each participant — specifically, whether the collection reached a particular target level. The reported data shows that 34 out of 43 participants met this collection target. The trial set a benchmark of at least 80% of participants needing to reach the target for the result to be considered potentially promising. The reported data shows the number who met the target was 34, though the total percentage figure was not separately reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00006244 · results posted 16 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people with multiple myeloma (a type of blood cancer), and all 36 completed the study. The trial was testing an immunotherapy approach that involved a chemotherapy drug called melphalan, stem cells that had been treated with a immune-signalling protein called IL-2, and then ongoing treatment with IL-2 and another immune protein called interferon. The trial was measuring how patients responded to this treatment, how long before the disease got worse, how many patients survived overall, and how many experienced serious side effects. The reported data shows that of the 36 participants, 15 had a complete remission (no detectable disease), 8 had a partial remission (disease reduced but still present), 10 had stable disease (disease neither improved nor worsened), and 3 had disease progression (disease got worse) in response to the initial treatment. The reported average time until the disease progressed was 1.61 years. At the time the results were recorded, 9 participants were reported as alive overall, and 4 participants were reported as being alive and still in remission. Regarding serious side effects (rated Grade 3–4, meaning severe or life-threatening on a standard medical scale), 1 participant under 56 years old experienced them, and no participants aged 56 or older were reported as experiencing them. The reported data shows these were the key numbers submitted for this trial. It is worth noting that some context — such as the total follow-up time or the full breakdown of survival figures — was not reported in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01937351 · results posted 12 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01937351) enrolled a total of 162 participants across two groups: a Primary Cohort of 134 people and a Roll-in Cohort of 28 people. The Roll-in Cohort was a smaller, separate group used to allow procedural familiarisation before the main study. The trial was measuring how a device called Pantheris performed when used to treat blockages in leg arteries — specifically looking at how often serious complications occurred and how well the device cleared the blockage. The reported data shows that for the primary safety measure — the proportion of participants free from a combined group of serious events (such as cardiovascular-related death, major limb amputation, heart attack, or significant device-related complications) over six months — the figure was reported as 82.4% in the Primary Cohort, whether analysed by the per-protocol or intention-to-treat method (two standard ways of counting participants in a trial). For the primary effectiveness measure — how often the device on its own reduced a blockage to less than 50% narrowing as assessed by an independent laboratory — the reported figures were 96.3% (per-protocol) and 94.0% (intention-to-treat). The reported data shows that at 30 days, 93.1–93.3% of primary cohort participants were free from those same serious events; 97.7–97.8% were free from complications in nearby blood vessels during the procedure; and 91.2% were free from needing an unplanned repeat procedure on the treated vessel at six months. For the secondary effectiveness measure — blockage reduced to less than 30% after the Pantheris device plus any additional treatment — the figures were reported as 78.7–79.0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01774097 · results posted 21 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 82 people in total — 40 in the treatment group (receiving a cell therapy referred to as "ALDHbr") and 42 in the placebo group (receiving an inactive substance called "vehicle"). Nearly all participants finished the trial: 38 in the treatment group and 40 in the placebo group completed it, with just 2 people in each group not finishing. The trial was measuring several things related to blood flow and circulation in the legs, including how long participants could walk on a treadmill, how many small "bypass" blood vessels (collaterals) could be seen on a special type of scan, blood flow in a leg artery, capillary (tiny blood vessel) perfusion, and blood pressure comparisons between the ankle and arm (called the ankle-brachial index, or ABI). The reported data shows the following results. For the primary (main) outcomes, the average change in treadmill walking time was reported as 2.2 minutes for the treatment group and 1.2 minutes for the placebo group. The average change in the number of collateral vessels visible on scan was 1.5 for the treatment group and 0.6 for the placebo group. For blood flow in the leg artery, both groups reported an average change of 0.2 mL per second. For capillary perfusion, both groups showed a small negative change — minus 0.42% for the treatment group and minus 0.25% for the placebo group, meaning a slight reduction was recorded in both. For the secondary (additional) outcomes, the pre-exercise ABI (ankle-to-arm blood pressure ratio measured before the treadmill test) was 0.61 for the treatment group and 0.64 for the placebo group, and the post-exercise ABI (measured after the treadmill test) was 0.30 for the treatment group and 0.34 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00040846 · results posted 16 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 participants, all of whom were assigned to Dose Level 1 (the group that did not receive the drug Campath). The trial was designed to look at several things following a stem cell transplant: the risk of death related to the transplant procedure itself within the first 100 days, the rate of a complication called graft-versus-host disease (GVHD — where transplanted donor cells attack the recipient's body), whether the transplanted cells successfully "took hold" in the body (called engraftment), and the rates of infection and disease relapse. No results were reported for any of the other five Campath dose groups (Dose Levels 2 through 6), so those figures are not available in the submitted data. The reported data shows that, within the group of 60 participants, 20% experienced transplant-related death within the first 100 days. Regarding graft-versus-host disease, 23.3% of participants were reported to have developed one form of GVHD, and a separate figure of 41.7% was also reported — likely reflecting acute and chronic GVHD respectively, though the data as submitted does not clearly label which figure corresponds to which type. On the question of engraftment, the reported data shows a range of figures across different measurement categories (3.3%, 18.3%, 70%, 8.33%, 1.7%, 3.3%, 80%, and 15%), but because the submitted results do not clearly label what each individual number represents, it is not possible to describe them in more detail without risking misrepresentation. The reported rejection rate was 3.3%. For the secondary outcomes, 91.7% of participants were reported to have experienced an infection within 100 days of the transplant, and 21.7% were reported to have had their disease relapse or progress within one year. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00408681 · results posted 20 January 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom were receiving a treatment (lithium carbonate, taken by mouth) for intestinal complications of a condition called acute graft-versus-host disease — a serious problem that can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient's body, including the gut. The trial was measuring whether participants showed a recovery in gut symptoms, and also looked at the physical state of the gut lining using a camera examination (endoscopy). Of the 20 people who started, 11 completed the study and 9 did not. The reported data shows that, for the main measure — gut symptom recovery — 10 out of 20 participants were recorded as having a complete response (meaning no remaining gut symptoms linked to the condition), 1 had a partial response (meaning some improvement but not full), 6 showed progression (meaning their condition worsened), and 3 had an outcome that was not clearly categorised in the data as provided. For the secondary measure looking at the gut lining through camera examination, the reported numbers across different time points and categories varied, with small numbers of participants (ranging from 0 to 3) falling into categories such as no improvement, early signs of healing, limited improvement, partial improvement, and complete recovery — though the precise timing and grouping of these endoscopy results was not fully detailed in the submitted data. The reported average duration of treatment with the study product was 30.5 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01436435 · results posted 26 August 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 241 people in a single group, all of whom received a procedure using the Jetstream Atherectomy System — a device designed to clear blockages in leg arteries. Of the 241 participants who started the trial, 177 completed it, while 64 did not complete it (the reasons were not detailed in the submitted data). The trial was measuring things like whether the treated artery showed signs of re-narrowing after 12 months, how well the procedure cleared the blockage at the time it was performed, changes in blood flow to the lower leg, and the number of serious unwanted events within 30 days. The reported data shows that the main thing being tracked — re-narrowing of the treated artery at 12 months, measured using an ultrasound scan — was recorded in 22.8% of patients. For the secondary measurements, the reported data shows that 98.3% of patients had the blockage reduced to 30% or less during the procedure itself. Blood flow to the lower leg was measured using a simple comparison of blood pressure at the ankle versus the arm (called an Ankle-Brachial Index, or ABI); the reported data shows that 73.5%, 54.7%, and 58.2% of patients showed a meaningful improvement in this measurement at different time points, though the specific time points for each figure were not clearly distinguished in the submitted data. The reported data also shows that 5 serious unwanted events (such as amputation, death, heart attack, or the need for a further procedure on the same vessel) were recorded within the first 30 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01330628 · results posted 15 June 2016
According to the results reported on ClinicalTrials.gov, this trial compared two procedures used to treat blocked leg arteries: one combining laser atherectomy (a technique that uses laser energy to clear the blockage) followed by balloon angioplasty (where a small balloon is inflated to widen the artery), versus balloon angioplasty alone. A total of 252 people joined the study — 170 in the laser-plus-balloon group and 82 in the balloon-only group. The trial measured two main things: how many participants avoided a repeat procedure on the same treated area within six months, and how many avoided serious complications (defined as death from any cause, major amputation of the treated leg, or a repeat procedure) within the first 30 days. The reported data shows that, at the six-month point, 123 out of the 170 people in the laser-plus-balloon group had not needed a repeat procedure on the treated area, compared with 43 out of 82 in the balloon-only group. For the 30-day serious complications measure, the reported data shows 158 out of 170 participants in the laser-plus-balloon group were free from those events, compared with 61 out of 82 in the balloon-only group. It is worth noting that not everyone completed the full follow-up period — 70 people in the laser-plus-balloon group and 40 in the balloon-only group did not complete the study, and the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01852591 · results posted 4 April 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01852591) involved a single group of 8 participants who received a vaccine called PCV13 (a pneumococcal conjugate vaccine). The trial was measuring how the immune system responded to the vaccine, particularly in the context of transplantation. Of the 8 people who started the trial, 5 completed it and 3 did not finish. The reported data shows that all 5 participants who completed the trial showed a positive immune response across each of the test categories measured — meaning their post-vaccination results were higher than their pre-vaccination results. The trial also tracked specific immune cell activity in more detail. For one type of immune cell response (CD4+ cells reacting to a vaccine component called CRM197), the reported figures ranged from 0.051% to 40.7% of CD4 cells. For another type of immune cell (CD8+ cells measured by a marker called IFN-gamma), the reported range was 0.00% to 2.69% of CD8 cells. A further CD8+ cell measurement (using a different marker called CD107a) showed a reported range of 1.19% to 8.94% of CD8 cells. These ranges likely reflect the lowest and highest individual results seen among the participants, though the data as submitted does not break this down further. It is worth noting that this was a very small trial with only 8 participants, and the reported data reflects only what was submitted to ClinicalTrials.gov for this specific study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01541644 · results posted 11 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people who were receiving the cancer drug bortezomib and had developed moderate to severe nerve-related symptoms (such as pain, tingling, or numbness) as a side effect — a condition called peripheral neuropathy. All participants received acupuncture. Of the 27 who started, 24 completed the trial and 3 did not finish. The trial was measuring whether acupuncture had any effect on those nerve-related symptoms, using two main tools: a nerve symptom scoring system called the TNSc, and a quality-of-life questionnaire called the FACT/GOG-Ntx, which runs on a scale of 1 to 100 where higher scores indicate worse symptoms and functioning. The reported data shows that the average score on the FACT/GOG-Ntx scale changed by 13.3 units over the 10-week study period compared to where participants started. It is worth noting that the other measurement tool used in this trial — the TNSc nerve scoring system — was flagged by the researchers themselves as producing results they considered invalid. This was because the scoring was carried out by a research nurse, whereas the original tool had been designed to be used by specially trained nerve specialists, and the reliability of using a nurse for this purpose had not been checked before the trial began. As a result, those TNSc figures were not reported as usable data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02271529 · results posted 26 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people and looked at a device called the Zilver PTX Drug-Eluting Peripheral Stent — a small mesh tube coated with a medication called paclitaxel that is placed inside a blood vessel. The main thing the trial was measuring was how much the stent's length changed at the moment it was deployed (put into place inside the body), comparing its length before and after deployment. The reported data shows that, on average, the stent length changed by minus 1.0% upon deployment — meaning the stent ended up very slightly shorter after being placed than it was beforehand. Of the 40 people who started the trial, 39 completed it, and 1 did not complete it. No reason for non-completion was provided in the reported data. The trial only reported one outcome measure, so no other numerical results were available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01175850 · results posted 6 October 2015
According to the results reported on ClinicalTrials.gov, this trial compared two procedures for treating narrowed leg arteries: a drug-coated balloon (DCB) and a standard balloon procedure called PTA (plain balloon angioplasty, where a small balloon is inflated to open the artery). The trial was run in two phases. In the first phase, 99 people received the drug-coated balloon and 51 received standard PTA. In the second phase, 121 people received the drug-coated balloon and 60 received standard PTA. The trial measured two main things at 12 months: whether the treated artery stayed open without needing further intervention (called "primary patency"), and a combined safety measure tracking serious events such as death within 30 days, major limb amputation, or the need for a repeat procedure on the treated vessel within 12 months. The reported data shows that for the primary patency measure — meaning the artery remained open and free from significant re-narrowing or the need for a repeat procedure — 82.2% of participants in the drug-coated balloon group met this outcome, compared with 52.4% in the standard PTA group. For the combined safety measure, 95.7% of the drug-coated balloon group were free from the serious events being tracked, compared with 76.6% in the standard PTA group. These are the figures as submitted by the trial sponsor; the trial was not designed to draw conclusions for individual patients. The reported data also shows results for several secondary (additional) measures at 12 months. A combined score of serious adverse events — including death, major amputation, blood clots at the treatment site, and repeat procedures — was recorded in 6.3% of the drug-coated balloon group and 24.3% of the standard PTA group. Death from any cause was recorded in 1.9% of the drug-coated balloon group and 0.0% of the standard PTA group. The need for a repeat procedure on the treated vessel was reported in 4.8% of the drug-coated balloon group versus 23.4% of the standard PTA group, and a repeat procedure specifically on the treated lesion (the original narrowing) was reported in 2.9% versus 20.6% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01132547 · results posted 2 July 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01132547) enrolled 22 people in total — 9 in the group receiving cyproheptadine hydrochloride (a medication) and 13 in the group receiving a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in body weight over 8 weeks in participants who were losing weight, comparing those who received the medication against those who received the placebo. Not everyone finished the trial: 5 of the 9 people in the medication group completed it, compared with 12 of the 13 in the placebo group. The reported data shows two primary things were measured. First, the number of participants who lost 5% or more of their body weight by the 8-week mark: 0 out of 9 in the medication group and 2 out of 13 in the placebo group met this threshold. Second, the change in a weight "Z score" (a number that compares a person's weight to what is typical for their age and size) from the start to the end of the trial: the medication group's Z score increased by 0.12 on average, while the placebo group's Z score decreased by 0.02 on average. For the secondary outcome — actual change in body weight in kilograms — the reported data shows the medication group gained an average of 0.18 kg, while the placebo group lost an average of 0.32 kg. It is worth noting that this was a very small trial, with only 22 participants at the start and even fewer completing it, which means the numbers above reflect a limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01273623 · results posted 4 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people in a single group (meaning everyone received the same treatment, with no comparison group). The trial was measuring changes in the size of a blood vessel's inner opening (called the luminal area) before and after a procedure called atherectomy — a technique used to remove build-up from inside blood vessels. A total of 26 participants completed the study, while 29 did not complete it. The reported data shows that before the atherectomy procedure, the average inner opening of the blood vessel measured 5.1 mm², and after the procedure this measurement rose to 8.3 mm². These measurements were taken using a specialised imaging tool placed inside the blood vessel. The reported data also shows that the narrowing of the vessel's diameter (how much the vessel was blocked) fell by 37% after the procedure. Regarding additional treatments used alongside the main procedure, the reported figures show that 62% of participants received one type of additional therapy, 31% received another, and 8% received a third — though the data as reported does not specify which therapy corresponds to which figure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00679055 · results posted 16 February 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00679055) looked at an experimental treatment called MK-0736 compared to a placebo (a dummy treatment with no active ingredient) in people with peripheral arterial disease — a condition where arteries in the legs become narrowed or blocked. The trial enrolled 14 participants in total: 8 received MK-0736 and 6 received placebo. The main thing the trial set out to measure was a change in the level of a protein called CD68, which is a marker for a type of immune cell (macrophage) found in fatty deposits in artery walls. It also aimed to measure changes in a biological marker related to inflammation called mRNA. The reported data shows that no numbers were provided for either the primary outcome (CD68 levels) or the secondary outcome (mRNA levels) — the results for these measures were not reported in the data submitted to ClinicalTrials.gov. Because of this, it is not possible to describe what those measurements showed. Regarding how many people completed the trial, the reported data shows that 6 out of 8 participants in the MK-0736 group and only 1 out of 6 in the placebo group finished the study. The reported data shows that for the one secondary outcome where a number was provided — how many participants stopped the study early because of an unwanted event — 0 participants in the MK-0736 group and 1 participant in the placebo group discontinued for this reason. No further detail about that event was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01086215 · results posted 3 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 500 people in total across four groups based on their condition: 212 with limb ischaemia (reduced blood flow to a limb), 201 with deep vein thrombosis (a blood clot in a deep vein), 73 with haemodialysis access problems (blockages in the blood vessel connections used for kidney dialysis), and 14 with other clotting conditions. The trial followed participants for up to 12 months and was measuring two main things: how much blockage in the treated blood vessels changed during the procedure itself, and how many participants experienced a new clot (rethrombosis) in the same vessel over the following year. The reported data shows that vessel blockage was scored on a four-point scale before and after the procedure, where a higher number means less blockage. The average change in score during the procedure — meaning the shift from more blocked to less blocked — was reported as 2.45 for the limb ischaemia group, 2.40 for the deep vein thrombosis group, 2.50 for the haemodialysis access group, and 1.95 for the other conditions group. Regarding rethrombosis over 12 months, the reported data shows that 21 limb ischaemia participants, 22 deep vein thrombosis participants, 15 haemodialysis access participants, and none from the other conditions group experienced a first rethrombosis episode. The data also recorded which additional treatments were used alongside the device during the procedure, though the trial did not report a comparison group treated differently, so these numbers describe what happened in these participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00153166 · results posted 30 September 2014
According to the results reported on ClinicalTrials.gov, this trial involved 48 people in total across three groups: 11 healthy volunteers, and 37 people with a condition called PAD (peripheral artery disease, which affects blood flow in the legs). Within the PAD group, 28 participants did not have diabetes, and results for this subgroup were also reported separately. The trial was measuring two things: how much glucose (sugar) the calf muscles in the lower leg were taking up, and how well the whole body was responding to insulin (the hormone that helps the body use sugar for energy). Participants with PAD were assigned to one of four treatment combinations involving two medicines — atorvastatin and pioglitazone — or dummy (placebo) versions of each. All 48 participants who started the trial completed it. The reported data shows the following numbers for the main outcome — calf muscle glucose uptake, measured in units called micromoles per kilogram per minute (a standard way of measuring how quickly muscles absorb sugar): healthy volunteers showed a value of 62.9, participants with PAD overall showed 48.6, and the PAD group excluding those with diabetes showed 49.5. For the second measure — whole-body insulin sensitivity, reported in milligrams per kilogram per minute — healthy volunteers showed a value of 5.0, while both the overall PAD group and the PAD-without-diabetes subgroup each showed a value of 3.4. The reported data does not include a breakdown of these numbers by which treatment combination participants received, so a comparison between the different treatment groups is not available from the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00439309 · results posted 1 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people in total — 54 received a product called VascuSeal and 15 received a comparison treatment called GELFOAM/THROMBIN. Both of these are products applied during vascular surgery (surgery on blood vessels) to help stop bleeding at the joins, or "anastomoses," where blood vessels are stitched together. All 69 participants completed the treatment phase, and most — 51 in the VascuSeal group and 13 in the GELFOAM/THROMBIN group — also completed the follow-up period. The reported data shows that the main thing being measured was "sealing success" — whether the stitched join stopped bleeding completely within 10 minutes of blood flow being restored, without needing to use a different method. The reported figures show that 90.7% of participants in the VascuSeal group and 86.7% in the GELFOAM/THROMBIN group met this definition. For one of the secondary measurements — "immediate sealing success," meaning the join stopped bleeding straight away with no waiting time — the reported figures were 51.5% of treated sites in the VascuSeal group compared with 10.5% in the GELFOAM/THROMBIN group. Overall sealing success across all treated sites was reported as 92.6% for VascuSeal and 89.5% for GELFOAM/THROMBIN. The reported data also shows figures for how long things took. The median time until bleeding stopped was reported as 1.0 minute for the VascuSeal group and 5.0 minutes for the GELFOAM/THROMBIN group. The median time from the last clamp being removed until the surgical wound was closed was reported as 53.5 minutes for VascuSeal and 42.5 minutes for GELFOAM/THROMBIN. No explanation for the difference in wound closure time was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01099215 · results posted 4 February 2014
According to the results reported on ClinicalTrials.gov, this trial tested an investigational product called PVS-10200, given at either a low dose (Cohort A) or a high dose (Cohort B), in people with a condition affecting a blood vessel in the upper leg called the superficial femoral artery. A total of 21 people were enrolled — 11 in the low-dose group and 10 in the high-dose group. Most participants finished the study: 10 from Cohort A and 9 from Cohort B, with one person in each group not completing it. The trial was primarily measuring whether serious "major adverse events" — defined as death, major amputation, or serious problems linked to the procedure or the product — occurred. The reported data shows that, for the primary outcome, zero participants in either the low-dose or high-dose group experienced a major adverse event. For a secondary look at major adverse events at a later time point, the reported data shows zero in the low-dose group and one participant in the high-dose group. When it came to serious adverse events more broadly (a wider category of significant medical problems), 7 participants in each group were reported to have experienced at least one. For adverse events and laboratory abnormalities, all 11 low-dose and all 10 high-dose participants were reported to have had at least one adverse event of any kind, while 1 participant in the low-dose group and 5 in the high-dose group had a notable laboratory abnormality recorded. The reported data also shows results for whether the blood vessel in the upper leg remained open (called "primary patency"), measured using ultrasound. At one time point, zero participants in either group had lost patency, with 9 participants in each group having evaluable ultrasound results. At a later time point, 4 out of a smaller number of evaluable participants in each group showed maintained patency, while 5 (low-dose) and 4 (high-dose) also had evaluable scans recorded — though it should be noted that not all participants had ultrasound data that could be fully assessed at every point, so these numbers reflect only those whose results could be evaluated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00753337 · results posted 30 December 2013
According to the results reported on ClinicalTrials.gov, this trial involved 123 participants who all received the Assurant Cobalt Iliac Stent — a small metal tube placed inside a blood vessel in the hip/pelvis area to help keep it open. All 123 participants completed the study. The trial was measuring a range of outcomes related to the stent procedure, including serious adverse events (unexpected harmful occurrences linked to the device or procedure), whether the treated blood vessel stayed open over time, and how well the procedure went overall. The reported data shows that the main safety outcome — called "Major Adverse Events" (serious harms linked to the device or procedure, including death, limb loss, or the need to re-treat the same vessel) — was recorded in 0.8% of participants over the nine-month follow-up period. For the secondary outcomes, the reported data shows that 100% of treated vessel segments assessed by ultrasound scan at nine months showed blood was still flowing through them (called "primary patency"). The device was reported to have successfully reduced the narrowing in the treated vessel to less than 30% in 97.5% of cases using only the study stent, and the same figure applied when any technique was used. Overall procedure success — meaning the narrowing was reduced and no major harmful event occurred before the participant left hospital — was reported for 96.7% of participants. Finally, 88.2% of assessed limbs showed an improvement of at least one stage on a scale (called the Fontaine classification) used to describe how severely blood flow to the legs is affected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01570309 · results posted 10 October 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 96 people in total — 48 in each group. One group received ergocalciferol (a form of vitamin D), and the other received a sugar pill (placebo). The trial was measuring two main things over 12 weeks: how well the inner lining of blood vessels was functioning (called "endothelial function"), and levels of certain inflammation markers in the blood. A total of 45 people in each group completed the trial, with 3 in each group not finishing. The reported data shows the following changes from the start of the trial to week 12. For blood vessel function — measured using a scoring method called the reactive hyperemia index (a way of gauging how blood vessels respond when blood flow is briefly restricted and then released) — the vitamin D group showed a median change of +0.13, while the sugar pill group showed a median change of −0.04. For inflammation, the trial tracked four different markers in the blood. A protein called hs-CRP changed by −0.17 mg/dL in the vitamin D group and −0.05 mg/dL in the sugar pill group. A signalling protein called interferon-gamma changed by −2.29 pg/mL in the vitamin D group and −2.8 pg/mL in the sugar pill group. Another marker called CXCL-10 changed by −7.45 pg/mL in the vitamin D group and −2.72 pg/mL in the sugar pill group. Finally, a marker called IL-12 changed by −10.96 pg/mL in the vitamin D group and −2.33 pg/mL in the sugar pill group. The reported data shows only the measured changes in these numbers across the two groups; no information about whether these differences were considered statistically meaningful was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00880230 · results posted 10 June 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 141 people who received the Scuba Iliac Stent System, a device placed inside a blood vessel in the hip/pelvis area to treat a narrowing or blockage. Of those, 134 completed the study, while 7 did not complete it. The trial was measuring a range of outcomes related to serious health events and how well the device performed, tracked over a period of up to 9 months. The reported data shows that the main (primary) outcome — a combined measure of serious events including heart attack, repeat procedures on the treated area, loss of the treated limb, or death within 9 months — was recorded in 5.2% of participants. For secondary outcomes tracked within the first 30 days, a broader group of serious vascular (blood vessel-related) events was recorded in 2.2% of participants. The reported data also shows that the device was successfully placed and retrieved in 95% of cases, and the overall procedure was considered successful — meaning the device was placed properly, the blockage was reduced to less than 30%, and no major in-hospital events occurred — in 86.5% of cases. Regarding how participants were feeling, the reported data shows that at 30 days, 93.8% of participants showed at least some improvement on a standard scale used to rate leg pain and circulation symptoms. At 6 months, 69.3% of participants met the criteria for maintained improvement, based on blood pressure measurements in the leg or continued symptom improvement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00822172 · results posted 22 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 163 people in total — 80 in one group and 83 in the other. All participants had peripheral artery disease (a condition where reduced blood flow to the legs can cause pain and difficulty walking). The trial compared two groups: one took cilostazol (a medicine for leg circulation) together with L-carnitine (a nutritional supplement), and the other took cilostazol together with a placebo (a dummy pill with no active ingredient). The main thing the trial measured was how long participants could walk on a treadmill before having to stop, tested at the start and again at 90 and 180 days (roughly 3 and 6 months). By the end of the study, 65 people in the first group and 64 in the second had completed the trial. The reported data shows that both groups recorded an increase in their maximum treadmill walking time from the start of the trial to day 180. Because the numbers were spread out unevenly, the researchers used a mathematical adjustment (called a log transformation) to summarise the changes — so the figures below are in "log minutes" rather than straightforward minutes. The cilostazol + L-carnitine group recorded a change of 0.241 log minutes (primary outcome) and 0.267 log minutes (a separately reported secondary measure), compared with 0.134 and 0.145 log minutes respectively for the cilostazol + placebo group. At the 90-day mark, the reported changes were 0.166 versus 0.139 log minutes. The reported data also shows changes in the time before leg pain first started during the treadmill test: at day 180, the figures were 1.065 log minutes for the combination group versus 0.896 for the placebo group; at day 90, they were 1.001 versus 0.815. Finally, a questionnaire asked participants to rate how difficult they found walking various distances (scored 0–100, where 100 means no difficulty at all). The reported change from the start to day 180 was a score improvement of 13.20 points in the cilostazol + L-carnitine group, compared with 6.57 points in the cilostazol + placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00896337 · results posted 3 July 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00896337) enrolled 125 participants, all in a single group called ORION, who received a device known as the Epic Stent — a small tube-like implant placed inside a blood vessel. Of the 125 who started, 100 completed the trial, while 25 did not finish. The trial was measuring how often serious device- or procedure-related problems occurred, as well as tracking deaths over time. The reported data shows that the main thing being measured — called "major adverse events" — covered serious outcomes such as death within 30 days, heart attack during the hospital stay, a repeat procedure on the treated blood vessel, or amputation of the treated limb, all tracked out to nine months. According to the results reported on ClinicalTrials.gov, 3.4% of participants experienced one of these major adverse events. For deaths specifically, the reported data shows figures recorded at several different time points: 0.0%, 0.8%, 1.8%, 3.7%, and 6.5% of participants — though the exact time point each of these figures corresponds to was not clearly labelled in the submitted data, so a precise breakdown cannot be provided here. It is worth noting that this trial had only one group, meaning there was no comparison group, so the numbers above simply describe what was observed in the people who received the Epic Stent rather than comparing it against another treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00518284 · results posted 13 March 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00518284) enrolled a very small number of participants — a total of 6 people across three of the four planned groups. No participants were enrolled in the Control group. Three people joined the "Proximal to Lesion + IV" group, one joined the "During Flow Arrest" group, and two joined the "During Flow Arrest + IV" group. Notably, none of the participants were recorded as having completed the trial — all six were listed under "not completed." The trial was designed to look at different ways of delivering a treatment during a procedure to open blocked leg arteries, measuring things like whether the treated vessel needed to be reopened later, changes in walking ability, and blood flow measurements. The reported data shows that almost all of the planned outcome measures — including the primary measure (whether the treated blood vessel needed to be reopened within 9 months) and most of the secondary measures (such as blood flow ratios, walking questionnaire scores, and blood pressure index changes) — have no numbers recorded at all. The data was not reported for these outcomes. The only figure available is for deaths from any cause: one death was reported in the "Proximal to Lesion + IV" group, and no deaths were reported in the other two groups that had participants. No further detail about these events was provided in the submitted data. Because so few people took part and no participant completed the trial, the results as submitted are extremely limited and do not provide a meaningful picture of what the trial originally set out to measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00427765 · results posted 19 January 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 164 participants, all of whom were in a single treatment group receiving a combination of two medicines called Busulfan and Melphalan. All 164 participants who started the trial were recorded as having completed it. The trial was measuring how long participants survived after receiving a stem cell transplant, with survival time counted from the date of the transplant until either the disease got worse or the person passed away for any reason. The reported data shows that the average overall survival time for participants in this group was 3 years following their transplant. No other outcome measures, such as secondary outcomes, appear to have been submitted in the results data available on ClinicalTrials.gov, so no additional figures can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00617279 · results posted 12 January 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00617279) enrolled a total of 31 people — 14 received a GORE PROPATEN Vascular Graft (a synthetic blood vessel graft) and 17 received a Disadvantaged Autologous Vein Graft (a graft made from the patient's own vein that was considered lower quality or harder to use). The trial was measuring whether the grafts remained open and carrying blood flow over time (called "patency"), and also tracking serious medical events in the first month after the procedure. Notably, the reported data shows that zero participants in either group were recorded as having "completed" the study, with all participants listed under "not completed" — this appears related to the study being terminated early. The reported data shows that for the main ("primary") patency measure at 12 months, 2 people in the synthetic graft group and 3 in the vein graft group had their graft remain open without any revision, while 4 people in each group were assessed at that time point. For major adverse events (serious medical complications requiring significant treatment, hospitalisation, or resulting in death) in the first month, 4 events were recorded in the synthetic graft group and 5 in the vein graft group. For the secondary measures — patency checked at one month and six months — the reported numbers of participants with open grafts were similar across both groups, though the total numbers assessed at each time point were small due to the early termination of the study. It is worth noting that because the trial was stopped before reaching its planned size, the numbers involved are very small, and the reported data reflects this limited scope. Several measurement breakdowns in the data appear to contain repeated values whose precise meaning (such as which row represents which subgroup) was not fully clarified in the submission, and some details were not reported in a way that allows complete interpretation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00667381 · results posted 16 November 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,004 people in total — 501 in a control group and 503 in an ultrasound group. All participants completed the study with no drop-outs recorded. The trial was looking at whether using ultrasound guidance during a procedure that involves inserting a small tube (sheath) into the large artery in the groin (the femoral artery) made a difference compared to a standard approach using X-ray landmarks. The main thing being measured was whether the sheath ended up in the correct part of the artery, confirmed by a special X-ray called an angiogram. The reported data shows that, among those whose angiogram results could be analysed (490 in the control group and 499 in the ultrasound group), 408 control patients and 431 ultrasound patients had the sheath placed in the correct position. The reported data also shows that the average time from starting the procedure to successful sheath insertion was 213 seconds in the control group and 185 seconds in the ultrasound group. For accidental punctures of the nearby vein (when this was not intended), 79 control patients and 12 ultrasound patients experienced this. Regarding vascular complications — a category that included things like bruising larger than 5 cm, unexpected blood loss, or damage to the blood vessel — 17 control patients and 7 ultrasound patients had one of these events recorded within 30 days. In a pre-planned smaller analysis of patients whose artery branched in an unusually high position (making accurate placement harder), 111 control patients and 123 ultrasound patients had successful sheath placement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00322387 · results posted 14 July 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 participants in total — 14 with Non-Hodgkin's Lymphoma (NHL) and 26 with Multiple Myeloma (MM). The trial was measuring the experience of participants who received a drug called plerixafor as part of a stem cell collection process before a transplant. Participants were given plerixafor in different ways (for example, at different times of day or after chemotherapy), and the trial tracked unwanted medical events (called adverse events), how well the drug moved stem cells into the bloodstream, and how quickly participants' immune systems recovered after their transplant. The reported data shows that across all 40 participants, 39 experienced at least one adverse event of any kind during the 12 months following their transplant. For the secondary outcomes, the trial measured the "fold increase" in a type of stem cell (CD34+ cells) in the blood after receiving plerixafor — essentially, how many times higher the stem cell count was compared to before the dose. The reported ratios varied considerably across the different groups, ranging from 1.2-fold up to 24.0-fold, with the highest figure seen in MM participants who had a low initial stem cell count and received plerixafor in the evening. Regarding transplant recovery, the trial tracked how many transplants resulted in immune cell recovery (called engraftment) within a target window of 12 to 21 days after the transplant. The reported data shows engraftment within that window was recorded across several of the groups, though figures varied, and some groups recorded zero transplants meeting the target timeframe. Where data for some sub-group breakdowns appeared incomplete in the submitted results, the full figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00602446 · results posted 30 March 2010
According to the results reported on ClinicalTrials.gov, this trial involved 3 participants, all of whom received a medicine called deferasirox every day for 6 months. The trial was measuring two things: firstly, how many participants stopped taking the medicine early because of side effects linked to the drug, and secondly, whether levels of iron stored in the liver changed over the 6-month period. The reported data shows that none of the 3 participants stopped taking deferasirox early due to drug-related side effects — the number who discontinued for that reason was reported as zero. For the second measure, the reported data shows that the average reduction in liver iron concentration (a measure of how much iron is stored in the liver) across the 3 participants was 5.6 milligrams per gram, comparing the level at the start of the study to the level after 6 months. Because only 3 people took part, it is worth noting this was a very small study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00445328 · results posted 2 October 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people in total — 42 in a group receiving a blood-thinning injection called dalteparin, and 42 in a group receiving another blood-thinning injection called unfractionated heparin. The trial was measuring whether either treatment was associated with the development of blood clots (known as thromboembolic events), such as deep vein thrombosis (a clot in the leg veins) or pulmonary embolism (a clot in the lungs). It also looked at a number of other outcomes including deaths from any cause, stroke, bleeding, and allergic reactions to the drugs. The reported data shows that, for the two main (primary) outcomes — confirmed blood clot events and a broader composite measure of verified blood clot events — zero participants in either group were recorded as having such an event. For the secondary outcomes, the reported data shows that no deaths occurred in the dalteparin group, while one death from any cause was recorded in the unfractionated heparin group. No strokes were recorded in either group. One participant in the unfractionated heparin group was reported to have had a major bleeding event, while no major or minor bleeding was recorded in the dalteparin group. No drug-related allergic reactions were reported in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00676494 · results posted 9 July 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 172 people, all of whom had peripheral arterial disease (PAD) — a condition where narrowed arteries reduce blood flow to the legs. The trial was looking at what happened after a procedure to treat a blocked or narrowed blood vessel in the leg. Of the 172 people who started, 158 completed the study and 14 did not. The main thing the trial was measuring was the number of participants who experienced a serious adverse event (an unwanted medical occurrence, such as death, a heart attack, a repeat procedure on the treated vessel or lesion, or amputation of the treated limb) within the first 30 days after their procedure. The reported data shows that 2 out of 172 participants experienced one of these serious adverse events within 30 days. At the 6-month mark, several additional measurements were recorded. A leg artery disease severity score called the Rutherford Classification — which runs from 0 (no symptoms) to 6 (severe tissue damage or gangrene) — averaged 1.5 across participants. A blood pressure ratio called the Ankle Brachial Index (ABI), which compares blood pressure in the leg to the arm (with a normal range being 1.0–1.2 and below 0.5 considered severe arterial disease), averaged 0.77 across participants. The reported data also shows that 147 out of the participants assessed at 6 months had not needed a repeat procedure on the originally treated area of the vessel by that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.