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:

• You are between 18 and 80 years old (any gender).
• You have ongoing leg pain, cramping, or non-healing wounds caused by poor blood flow to your lower limb (a condition that falls into certain severity categories known as Rutherford 2, 3, 4, or 5 — confirm with trial site if unsure which applies to you).
• You (or your legal guardian) are willing to sign a consent form and attend all required follow-up appointments.
• Imaging shows that one or more blockages or narrowings of at least 70% are present in specific leg arteries (the superficial femoral artery and/or the upper part of the popliteal artery).
• The affected artery measures between 4.0 mm and 6.5 mm wide.
• The total length of the blocked or narrowed area is between 10 mm and 140 mm, and can be fully covered by a single stent (or up to 120 mm if the artery is completely blocked).
• At least one artery below the knee remains reasonably open (less than 50% narrowed) all the way down to the ankle or foot.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or anyone (male or female) planning to have a child.
• People who have already had, or are planned to have, a major amputation at or above the ankle.
• People who are known to be allergic or sensitive to materials used in the device or related medications, including nitinol (a metal alloy), paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, or contrast dye used in imaging.
• People with significantly reduced kidney function (a blood test result called serum creatinine at 2.5 mg/dL or higher) or who are currently on dialysis.
• People with known bleeding disorders or serious problems with blood clotting that cannot be corrected, or who have a very low platelet count.
• People whose target artery has already been treated with a stent in the past.
• People whose target artery was treated with a drug-coated balloon less than 12 months before joining the trial.
• People who are not expected to live longer than 1 year.
• People who have received clot-dissolving (thrombolysis) treatment within the 48 hours before joining the trial.
• People who have had a serious health event in the past 3 months, such as severe heart failure, unstable chest pain, heart attack, mini-stroke or stroke, serious mental health conditions, severe infections, stomach or bowel bleeding, or a serious blood-clotting disorder.
• People who are currently taking part in another clinical trial involving a drug or medical device.
• People whom the trial doctor considers unsuitable for any reason.
• People whose target artery has an abnormal bulge (aneurysm).
• People with heavily calcified (hardened) blockages in the target artery (confirm with trial site).
• People whose blockage would require special cutting or laser tools to treat before the procedure.
• Cases where the guidewire or balloon used during the procedure cannot pass through the blockage.
• People with a sudden (acute) blockage or blood clot in the target artery at the time of joining.

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