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 aged 18 or older
• People who have been told about the study, agree to take part, and have signed an approved consent form
• People who understand how long the study runs, are willing to attend follow-up visits, and agree to complete required tests
• People with a Rutherford Classification score of 2, 3, 4, or 5 — a scale used to measure the severity of reduced blood flow in the legs (confirm with trial site)
• People who have a new or re-narrowed blockage in specific leg arteries (the superficial femoral artery and/or the popliteal artery), with at least 70% narrowing confirmed by imaging
• People whose target artery has not had a stent placed in the exact area being treated, or if a stent was placed previously, it is at least 3 cm away from the treatment area
• People whose blockage in the target area is at least 10 cm long — there is no upper length limit
• People with severe calcium buildup in the artery walls, as seen on imaging, meeting a specific grading standard (PACSS Grade 4: calcium on both sides of the artery wall, extending at least 50 mm in length)
• People with multiple blockages where the gap of healthy vessel between them is no more than 3 cm — these may be counted as one lesion at the treating doctor's discretion
• People whose target blood vessel measures between 4 mm and 6.5 mm in diameter by visual estimate
• People who have at least one open artery below the knee continuing to the ankle (less than 50% narrowed), connected to the treated artery
• People in whom a guidewire has already been successfully passed through the blocked area during the procedure

Who may not be able to join:

• People in whom the guidewire could not be successfully passed through the blocked area
• People who have a fresh blood clot present in the blockage area
• People who have an abnormal bulging (aneurysm) in the target blood vessel
• People who already have a stent within the target blockage area, or within 3 cm of it in the target vessel
• People who have previously had vascular surgery on the target area
• People who have had a stroke or heart attack within the 3 months before enrolling
• People currently enrolled in another research study involving an investigational drug, device, or biological treatment that has not yet reached its main endpoint
• People with a life expectancy of less than one year
• People with known allergies or sensitivities to heparin, aspirin, other blood-thinning medications, or contrast dye used in imaging, where these cannot be adequately managed before the procedure
• People with a Rutherford Classification score of 0, 1, or 6 (either very mild or the most severe category of reduced blood flow)
• People with significant gastrointestinal bleeding or a blood-clotting condition that would make blood-thinning medication unsafe
• People currently taking medication that suppresses the immune system
• People who are pregnant or breastfeeding
• People who have had a major amputation (defined as amputation above the ankle) in the same leg as the treatment area

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