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 participate and sign an approved consent form
• People who are able to walk on their own or with a non-motorised walking aid (such as a cane or walker)
• People who have been diagnosed with peripheral artery disease (PAD) — a condition where blood flow in the leg arteries is reduced — at a moderate level of severity (confirm with trial site for exact classification)
• People whose general health suggests they are expected to live for more than 12 months, as assessed by the treating doctor
• People who have a new (not previously treated) build-up of fatty deposits blocking one or more specific leg arteries (the main thigh artery and/or the artery behind the knee)
• People whose blocked artery is narrowed by 70% or more, as assessed during an imaging procedure
• People whose blocked area measures 150mm or less in total length
• People whose artery is completely blocked for less than 100mm of that total length
• People whose artery is at least 4.0mm wide in the area near the blockage
• People in whom a guidewire was successfully passed through and beyond the blocked area during the procedure, without causing serious complications
• People who have at least one open artery below the knee that carries blood flow to the foot (less than 50% narrowed)
• People whose blocked artery has moderate to severe calcium build-up, graded using a specific research scoring system

Who may not be able to join:

• People who currently have an active infection being treated with antibiotics
• People for whom a stent is already planned to be placed in the target artery
• People who have tested positive for COVID-19 within the past two weeks and still have symptoms
• People who are pregnant or currently breastfeeding
• People who had a sudden, severe loss of blood flow to the affected leg within the 7 days before the procedure
• People who had a stroke within the 60 days before the procedure
• People who had a heart attack within the 60 days before the procedure
• People who were hospitalised within the last 60 days due to unstable heart disease or another serious uncontrolled health condition
• People who cannot take aspirin or blood-thinning medications required for the procedure and follow-up
• People who have a known allergy to the dye used in imaging procedures that cannot be adequately managed with pre-treatment medication
• People with a history of blood clotting disorders, or serious reactions to a blood-thinning medication called heparin
• People with poor kidney function above a certain level (unless already on dialysis), based on a blood test taken within the last 30 days (confirm with trial site for exact values)
• People who are planned to have a major amputation of the affected leg above the ankle
• People who had another procedure on the affected leg within the 14 days before this procedure, or have one planned within 30 days after, not including diagnostic imaging
• People currently taking part in another clinical trial for a device or drug that the treating doctor believes would interfere with this study
• People whose blockage requires the use of certain specialist medical devices to treat it (confirm with trial site for specific device types)
• People who have a significant blockage (more than 50% narrowed) in the arteries leading into the treatment area — such as the hip or groin arteries — that has not been successfully treated
• People who need treatment of an additional artery blockage lower down in the same leg at the time of this procedure

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