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 given written consent to participate in the trial
• People with a Rutherford classification (a scale used to measure leg blood flow problems) between 2 and 6
• People whose affected blood vessel measures between 2mm and 7mm in diameter
• People whose target blocked artery has a narrowing greater than 70%, as judged by visual assessment
• Multiple blockages close together with a healthy gap of 3cm or less between them may be counted as a single lesion (confirm with trial site)

For the above-the-knee group:

• People whose target blockage is located in the superficial femoral artery or the popliteal artery, above the knee joint
• People who have at least one open artery below the knee running down to the ankle
• People for whom any upstream artery narrowing (in the iliac artery) has been successfully treated, leaving less than 30% narrowing remaining and no complications

For the below-the-knee group:

• People whose target blockage is in an artery below the knee
• People for whom any upstream artery narrowing (from the iliac artery to the blockage) has been successfully treated, leaving less than 30% narrowing remaining and no complications

Who may not be able to join:

• People whose single target blockage spans both above and below the knee
• People for whom minimally invasive (endovascular) procedures on the leg arteries are not considered appropriate
• People for whom a major amputation above the ankle has already been planned for the affected leg
• People who have previously had bypass surgery on the target blood vessel
• People who have had open surgery within the past 30 days
• People who have planned vascular surgery on the affected leg within 30 days after the trial procedure
• People who have a medical condition listed as a contraindication for the Oscar device — for example, uncorrected bleeding disorders or active blood infection (sepsis) (confirm with trial site)
• People who are currently on kidney dialysis
• People who are currently participating in another clinical trial where the main study results have not yet been collected
• People who do not have the mental capacity to provide informed consent
• People under judicial protection, guardianship, or supervised protection arrangements (applicable in France only)

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