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:

• Adults between 18 and 80 years old, of any gender
• People who have been diagnosed with peripheral artery disease (PAD) affecting the legs — a condition where blood flow to the legs is reduced due to narrowed arteries
• People whose symptoms fall within a specific range of severity (Rutherford classification 2 to 5 — this covers symptoms from mild leg pain during activity through to minor tissue damage; confirm with trial site)
• People who are willing to participate, sign a consent form, and attend all required follow-up visits
• People whose affected artery in the upper thigh or behind the knee meets specific imaging criteria, including: a narrowing of 70% or more but not fully blocked, with the problem area measuring between 20mm and 250mm in length; OR a fully blocked section no longer than 150mm; OR a series of problem areas with a total length of 250mm or less, where any fully blocked sections total no more than 150mm
• People whose affected blood vessel measures between 3.5mm and 7.5mm in diameter as seen on imaging
• People in whom a specific medical tool used during the procedure is able to successfully reach and cross the affected area
• People where, after an initial balloon procedure, the remaining narrowing is 50% or less and there is no significant tearing of the vessel wall (confirm with trial site)
• People where the artery supplying blood into the leg from the hip area is either sufficiently open or has been successfully treated during the procedure (confirm with trial site)
• People who have at least one open blood vessel running from the knee down to the ankle or foot

Who may not be able to join:

• People who have a condition involving inflammation of the blood vessels, such as vasculitis or Buerger's disease
• People with serious blood clotting disorders or severe uncontrolled infections that make a procedure unsafe
• People with known allergies or medical reasons to avoid aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye, or related medications
• People who have had an amputation above the ball of the foot in either leg
• People with severely reduced kidney function (based on a specific blood test result; confirm with trial site)
• People who have received clot-dissolving treatment in the 48 hours before the procedure
• People who have had a heart attack in the 30 days before the procedure
• People who have had major surgery (such as open heart surgery, open abdominal surgery, or open surgery for artery disease) in the 30 days before the procedure
• People who have had bleeding in the digestive tract in the 3 months before the procedure
• People who have had a stroke in the 6 months before the procedure
• People whose life expectancy is less than 12 months
• People who have previously had a stent, drug-coated balloon, or bypass surgery in the specific artery being treated
• People in whom certain other surgical tools (such as atherectomy, laser, or cryoplasty devices) are used in the target area during the procedure
• People who are pregnant, breastfeeding, or planning to become pregnant
• People who are currently taking part in another clinical trial involving an investigational drug or device
• People considered unsuitable for enrolment based on the treating doctor's judgement
• People whose affected artery shows heavy calcium buildup on imaging
• People who have an abnormal bulge (aneurysm) in the affected blood vessel
• People who have a recent or developing blood clot in the affected vessel
• People who have previously had a graft procedure in the affected leg

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