Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• A person (or their legally authorised representative) has signed a consent form approved by the relevant ethics committee before any study procedures begin.
• The person agrees not to take part in any other trial involving an investigational drug or device for at least 12 months after the procedure (non-invasive studies such as questionnaire-based research are allowed).
• The person has a serious, ongoing condition called chronic limb-threatening ischaemia, classified at a severity level known as Rutherford category 4 or 5, meaning they have significant pain or wounds related to poor blood flow in a limb.
• The person is 18 years of age or older.
• The person agrees to attend all required follow-up visits, including imaging of their blood vessels (angiograms).
• The blockage or narrowing being treated is located in specific arteries below the knee (the tibioperoneal trunk, anterior tibial artery, posterior tibial artery, or peroneal artery).
• The blockage is located in the upper two-thirds of those below-knee arteries and is at least 10 cm above the ankle joint.
• Up to two blockages in up to two different arteries may be treated.
• A thin wire used to cross the blockage has already been passed through successfully before the person is enrolled in the trial.
• The blood vessels beyond the blockage, including those in the foot, must be largely open and free of significant narrowing (less than 50% blocked).
• Any blockages above the knee in the same limb must have been successfully treated (leaving less than 30% narrowing, with no complications) either during or within 30 days before the main procedure.
• The target artery must measure between 2.75 and 3.75 mm in diameter as seen on imaging.
• The blockage being treated is either new or a re-narrowing of at least 70% — but must not be inside a previously placed stent.
• The total length of all blockages being treated must be no more than 11 cm, and each individual blockage must be more than 14 mm long.
• The total length of the scaffold (device) used must not exceed 12 cm and must cover at least 2 mm of normal vessel on each side of the treated area.
• The target artery must not have any other significant blockages (50% or more) outside the area being treated.
• If two separate blockages are being treated, there must be at least 2 cm of clear, unaffected vessel between them.
• Placing the scaffold must not block access to any of the main named arteries branching off in that area.
• Any blockages in other arteries below the knee (outside the target artery) must be successfully treated before the person is enrolled, without complications, and without using drug-coated or atherectomy (plaque-removal) devices.
• The person has suitable access through a blood vessel in the groin area (either from the opposite leg or from the same leg approaching from the front).
• At least one artery below the ankle in the treated limb must be fully open and free of significant blockage.

Who may not be able to join:

• People with a Body Mass Index (BMI) below 18 (considered underweight).
• People who are pregnant, breastfeeding, or planning to become pregnant during the follow-up period of the study (people of childbearing potential must have a negative pregnancy test within 28 days before the procedure and agree to use contraception for 6 months).
• People whose life expectancy is estimated to be less than one year, in the treating doctor's opinion.
• People who are permanently bedridden.
• People with a known allergy or medical reason to avoid the materials used in the device or its breakdown products (sirolimus, certain plastics and lactic acid), study medications including antiplatelet drugs, or contrast dye used in imaging — unless they can be safely pre-treated for the allergy.
• People who have a planned surgery or procedure within 6 months after the main procedure that would require stopping antiplatelet (blood-thinning) medication.
• People who have had a procedure to restore blood flow in the target artery within the previous 3 months.
• People who have previously had a major amputation (toe or higher) of the leg being treated; amputation of the other leg is allowed.
• People who have another planned surgical or blood vessel procedure within 6 months after the main procedure (planned minor amputations such as a toe or part of the foot are allowed).
• People with an ankle-brachial index (a blood pressure comparison between the ankle and arm) of 0.39 or higher, indicating that ischaemia may not be severe enough (confirm with trial site).
• People whose foot wounds or ulcers are caused only by nerve damage (neuropathic), with no blood flow problem involved.
• People with bone infection (osteomyelitis), gangrene above the toe joints, large areas of tissue loss with exposed tendons, deep heel ulcers, or purely nerve-related ulcers.
• People with poorly controlled diabetes, shown by a blood sugar marker (HbA1c) above 10%.
• People who have had a stroke or heart attack within 3 months before the procedure.
• People with acute kidney failure, severe or end-stage chronic kidney disease (eGFR below 30 mL/min), or who need dialysis.
• People with an active infection anywhere in the body.
• People who are taking medication that suppresses the immune system, or who have a known immune system or autoimmune condition (such as HIV, lupus, rheumatoid arthritis, or severe asthma requiring immunosuppressive medication).
• People with an active cancer (receiving or scheduled to receive cancer treatment within one year before or after the procedure), certain blood disorders, or abnormal blood counts (including low platelets, low white blood cells, or low haemoglobin).
• People who are legally unable to make decisions for themselves or consent to participation.
• People with serious additional health conditions, psychological issues, or a history of substance misuse (such as alcohol or drug dependence) that in the doctor's opinion could prevent them from following study requirements; this includes people with a symptomatic COVID-19 infection in the past 2 months or a positive COVID-19 test in the past month.
• People whose imaging shows blood clots or cholesterol debris in the target or nearby blood vessels.
• People where a non-target blockage is located in a specific segment of the artery behind the knee (popliteal P3 segment), or where atherectomy (plaque removal) has been used on a non-target blockage.
• People with an aneurysm (bulging artery) or fresh blood clot in the aorta or leg arteries.
• People who have had a bypass graft below the knee in the leg being treated.
• People who have a previously placed stent in the target artery.
• People where the target artery has significant blockages (50% or more) outside the permitted treatment zone.
• People where the blockage has very severe calcium buildup (classified as PACSS grade 4) (confirm with trial site).
• People where blockages in the arteries feeding the treated area (including the lower section of the artery behind the knee) could not be successfully cleared.
• People without an open artery in the foot, or without continuous open pathways through the foot arteries connected to the target vessels.
• People where treating the blockage would require placing scaffolds in both branches of a forked artery at the same time (known as a "kissing scaffold" technique), which is not permitted.
• People where the artery could not be successfully opened with a balloon before the scaffold is placed.
• People where atherectomy (plaque-removal treatment) is planned for any target or non-target blockage.

Important: Always verify eligibility with the trial site directly before applying.