Phase 3 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 aged 18 or older
• People who are currently hospitalised with a serious limb circulation condition causing rest pain or a non-healing wound, ulcer, or limited area of tissue loss that has been present for more than 2 weeks, along with at least one abnormal blood flow measurement in the leg or foot
• People who have recently had a successful procedure to open blocked arteries in the lower leg (below the knee, with or without treatment of arteries above the knee as well), performed within the 7 days before joining the trial
• People who are enrolled in the French Health Insurance system
• People who are able to understand and sign a written consent form
• Women who could become pregnant must have a negative pregnancy blood test and be using an adequate form of contraception

Who may not be able to join:

• People whose limb circulation condition falls outside the specific severity range required — either too mild or too severe (including severe gangrene extending beyond the toes)
• People who had a sudden, severe loss of blood supply to a limb (acute limb ischemia) within one month before the qualifying procedure
• People with a low platelet count (below 100×10⁹/L)
• People who need to take two blood-thinning medications together for a reason other than their leg artery condition
• People who need to take blood-thinning medication (such as warfarin or a direct oral anticoagulant), except for a low dose of rivaroxaban (2.5 mg twice daily)
• People with a known allergy or sensitivity to aspirin or clopidogrel
• People who have had a significant bleeding episode, active bleeding, or a condition considered a serious bleeding risk in the last 6 months (this may include stomach ulcers, certain cancers, recent brain or spinal injury, enlarged veins in the food pipe, or major blood vessel abnormalities in the brain or spine)
• People with severe liver disease or any liver condition that affects blood clotting
• People who require dialysis or kidney replacement therapy, or who have very poor kidney function (confirm specific thresholds with trial site)
• People who have had a heart attack or serious cardiac event within the 30 days before joining the trial
• People who have experienced a major injury or accident within the 30 days before joining the trial
• People with a documented history of bleeding in the brain, stroke, or a temporary stroke-like episode (TIA)
• People with a known active cancer (excluding certain common skin cancers)
• People with poorly controlled diabetes, as judged by the treating doctor
• People with severely uncontrolled high blood pressure, as judged by the treating doctor
• People who are currently taking part in, or have participated in within the last 30 days, another clinical trial involving a drug or medical device
• People who have a close personal or professional relationship with the trial site (such as a family member or employee of the investigating team)
• People for whom follow-up appointments or treatment compliance are expected to be very difficult to maintain
• People who are detained or deprived of liberty
• People who are under legal guardianship or a form of legal protection
• People who are currently pregnant or breastfeeding

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