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 have given written agreement to take part in the study
• People experiencing symptoms of reduced blood flow to the lower legs, rated at a moderate level of severity (Rutherford classification 2 to 4) (confirm with trial site)
• People who have at least one new or re-narrowed blockage in a specific artery in the upper leg (the superficial femoral artery and/or popliteal artery), located in a particular section of that artery above the knee
• People whose blocked artery is narrowed by more than 60%, as confirmed by imaging
• People whose blocked section of artery is shorter than 150mm and could be fully covered by the specific medical balloon device being tested in this trial, with adequate coverage beyond each end of the blockage
• People whose target artery measures between 4.0 and 8.0mm in diameter, matching the size range of the device being tested
• People who have at least one open, unblocked vessel continuing down toward the ankle, with no major narrowing along its length
• People whose arteries leading into the treatment area are either clear of major narrowing, or were successfully treated at least 30 days before the study procedure

Who may not be able to join:

• People with a life expectancy of less than 2 years
• People with a cancer diagnosis where treatment has not been completed or the cancer is not considered cured
• People who have another surgical or medical procedure planned within 30 days after the study procedure
• People with significantly reduced kidney function or who are on dialysis
• People with an active infection or inflammation at the planned needle insertion site
• People experiencing sudden, severe loss of blood flow to the lower leg (acute limb ischemia)
• People whose artery problem is caused by something other than a build-up of fatty deposits — for example, inflammation of blood vessels or abnormal vessel development
• People who would need certain other devices or treatments used at the same time, such as a drug-coated stent, another drug-coated balloon, or specific procedures to remove plaque
• People whose target artery has very heavy calcium build-up meeting specific imaging criteria for severity and length (confirm with trial site)
• People who have a blood clot confirmed by imaging inside the target artery
• People whose target blockage would require a permanent stent to be placed as the main treatment
• People who have a tear, hole, or significant injury in the target artery at the time of enrolment
• People who have had a previous bypass graft or stent too close to the target area, or a stent in the pelvic artery area that would block the treatment device from passing through
• People who have had a significant bleeding event in the stomach, intestines, or elsewhere in the past three months
• People with a known disorder affecting blood clotting that is not well controlled
• People who have had a heart attack or stroke within the 30 days before the procedure
• People with known allergies or intolerances to medications required for the procedure, contrast dye used in imaging, or materials used in the device (including paclitaxel and nitinol)
• Women who are pregnant or of childbearing age and not using effective contraception
• People currently enrolled in another research trial (before that trial's primary results have been analysed), or people who have previously been enrolled in this same study

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