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 willing to give written consent before the procedure on the target artery is carried out
• People who are willing to attend the required follow-up appointments as scheduled by the trial
• People with leg artery disease classified as Rutherford-Becker category 2 to 5 (ranging from mild leg pain during exercise to tissue loss/non-healing wounds), with a blood pressure ratio between the ankle and arm of 0.9 or below when resting
• People with a blockage or narrowing of more than 50% in the common femoral, superficial femoral, and/or popliteal artery (arteries in the upper and lower thigh/behind the knee)
• People with one or more narrowed or blocked sections within the same artery, with no restriction on the total length of the affected area
• People with a new blockage or a re-narrowed/re-blocked area (including blockage within a previously placed stent), where the affected artery measures between 4.0 mm and 8.0 mm in diameter, with no length restriction
• People whose artery can accommodate multiple RENZAN stents placed with a required overlap of 0.5–1 cm
• People who have a clear, unblocked artery supplying blood to the treated area, confirmed by imaging — if a nearby artery (in the pelvis) needed treatment first, that treatment must have been successful, leaving less than 30% narrowing remaining
• People whose blockage can be successfully crossed with a guidewire and widened to match the size of the planned stent, as assessed by the treating doctor
• People with at least one open, untreated outflow artery in the lower leg (below the knee) with less than 50% narrowing, confirmed by imaging

Who may not be able to join:

• People with Rutherford-Becker category 6 leg artery disease (the most severe stage, involving major tissue loss)
• People whose artery condition would require the use of devices that remove plaque buildup before stenting
• People whose treatment would involve a drug-coated balloon or drug-coated stent
• People whose artery cannot be adequately widened to match the size of the planned stent, leaving more than 20% narrowing, as assessed by the treating doctor
• People who would need more than one type/brand of stent used at the same time
• People whose artery has significant twisting or other features that prevent the stent from being safely delivered to the affected area
• People who had a heart artery procedure within the 90 days before this treatment, or who have one planned within 30 days after this treatment
• People with a known allergy or intolerance to nitinol (a metal alloy made of nickel and titanium, commonly used in stents)
• People who cannot safely take dual antiplatelet therapy (two blood-thinning medications used together) or blood-thinning medication, for any reason
• People who have a fresh blood clot present in the affected artery before the guidewire is passed through
• People who had clot-dissolving treatment in the target artery within 72 hours before this procedure
• People who have had a blood clot in a vein or vein inflammation within the previous 30 days
• People who have been receiving kidney dialysis within the previous 30 days
• People who have had a stroke within the previous 90 days
• People who are pregnant or who could become pregnant
• People with a life expectancy of less than one year
• People currently taking part in another clinical research study that has not yet reached its main outcome point at the time of screening for this trial
• People who have only one open outflow artery in the lower leg and that artery has a significant narrowing of 50% or more, confirmed by imaging

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