Peripheral Arterial Disease Trial, Recruiting

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

Who might be able to join this trial:

• People who are willing and able to give informed consent and can follow the study requirements, including all follow-up visits
• People who, in the doctor's opinion, are expected to live for more than one year
• People who are over 18 years of age
• People who have serious symptoms of reduced blood flow to a limb — specifically rest pain or minor tissue loss — that cannot be managed with medication alone and where a procedure to open blocked blood vessels is considered necessary by the treating doctor
• People who have narrowed, re-narrowed, or completely blocked arteries below the knee, confirmed by imaging before the procedure
• People who have diabetes and/or have been receiving kidney dialysis for at least 6 months (diabetes group: kidney function must meet a specific threshold within 30 days of the procedure; dialysis group: dialysis must have been ongoing for at least 6 months — people with both diabetes and dialysis would be placed in the dialysis group only)
• People whose target blocked artery can be successfully crossed with a guidewire during the procedure
• People with a blocked artery located below the knee, with treatment of a specific lower section of the artery behind the knee also permitted if the blood vessel is not too wide (confirm with trial site)
• People whose target blood vessel reconnects at or above the ankle, with the treated section extending no more than 10mm past the ankle, and where blood flow continues to the foot (or at least one connecting vessel supplies the foot, depending on which artery is treated)
• People whose target blood vessel measures between 2.5mm and 4.5mm in diameter
• People where only one artery will be treated with the study device, and where any other nearby blocked arteries are treated first without causing complications
• People where the total length of artery to be treated with the study device is less than 250mm, with individual treated sections separated by at least 30mm of healthy tissue
• People where a preparatory balloon procedure on the target artery produces a result of 50% or less blockage without causing serious complications, before the study device is inserted
• People where any blockages in the larger arteries above the knee can be treated during the same procedure, before the lower-leg arteries are addressed, with a healthy gap of more than 30mm between treated sections
• People where the study device can be delivered through an approach that travels in the same direction as blood flow (confirm with trial site)

Who may not be able to join:

• People who, in the doctor's opinion, are unlikely to complete up to 12 months of follow-up after the procedure
• People who are pregnant or planning to become pregnant during the trial
• People who are breastfeeding or planning to breastfeed during the trial
• People with an active, uncontrolled infection throughout the body, including blood infections
• People with confirmed active bone infection in the target leg above the toe bones (bone infection limited to the toes only is permitted)
• People who have a wound above the ankle or on the heel
• People who have had, or are planning to have, a major amputation above the ankle on the target leg (minor amputations such as toe or partial foot removal are permitted)
• People whose overall health condition is too poor to safely undergo an endovascular procedure, in the treating doctor's opinion
• People in the diabetes group whose kidney function falls below the required threshold within 30 days of the procedure
• People in the dialysis group who have been receiving dialysis for less than 6 months
• People who are unable to take blood-thinning or anti-clotting medications as required by the treating facility
• People with known allergies to heparin, antiplatelet drugs, or other anti-clotting medications that cannot be managed adequately around the time of the procedure
• People with known allergies to Paclitaxel or Sirolimus, which are coatings used on certain medical balloons
• People with known allergies to contrast dye used in imaging that cannot be adequately managed before the procedure
• People with known allergies to nitinol or nickel (materials used in the study device)
• People who are currently enrolled in another clinical trial of an investigational device or drug that would affect this study's results
• People who have had a stent placed in, or bypass surgery on, the target blood vessel previously
• People who had any previous treatment of the target blood vessel within 30 days before the procedure
• People where imaging shows a blood clot present within the arteries of the target limb
• People where the required procedural access approach cannot be achieved
• People whose blocked artery has characteristics that, in the doctor's opinion, are not suitable for standard endovascular techniques
• People with more than 50% narrowing in the larger arteries feeding blood into the leg that cannot be successfully treated
• People where the target artery still has more than 50% narrowing, a serious tear, an abnormal bulge, or a clot after the preparatory balloon procedure
• People where follow-up imaging 15 minutes after treatment cannot be obtained to check whether the artery has re-narrowed

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