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 who are legally able to give consent
• People who have leg pain during activity or at rest that limits daily life, at a specific level of severity as measured by a standard scale (Rutherford-Becker scale 2–4), with reduced blood flow to the lower leg confirmed by a standard pressure test
• People who have a single blockage or narrowing of more than 50% in the main artery running down the thigh (the superficial femoral artery)
• People whose blocked or narrowed section of artery is no longer than 150 mm in total, whether it is one long blockage or several smaller ones close together
• People whose affected artery measures between 3.0 mm and 5.0 mm in diameter, as estimated visually during assessment
• People whose artery blockage is positioned at least 3 cm above the knee joint and at least 2 cm below where the deep femoral artery branches off
• People who have at least one artery below the knee that remains open (less than 50% narrowed) all the way to the ankle or foot
• People whose blocked artery can be crossed and widened using standard procedural tools
• People who would also be eligible for open surgical repair if that became necessary
• People who are willing to attend all scheduled follow-up visits and tests, and who are able and willing to sign an informed consent form

Who may not be able to join:

• People who have a blood clot visible in the target artery on imaging before the procedure begins
• People who had a clot-dissolving treatment in the target artery within 72 hours before the procedure, where the clot was not fully cleared
• People who have significant narrowing (more than 50%) in the arteries leading into the treatment area (the iliac or common femoral arteries) that was not successfully treated beforehand, and where blood flow would be considered too poor to support a bypass graft
• People who still have 30% or more narrowing remaining after treatment of any upstream artery blockage
• People who already have an artificial (synthetic) graft in the artery on the same side as the target lesion
• People who have an aneurysm (abnormal bulging) in the femoral artery on the same side, or in the target artery or nearby artery
• People who have a blockage in the corresponding artery on the opposite leg that needs treatment at the same time, or within 30 days before or after this procedure
• People who would need a stent placed using a backward (retrograde) approach through the artery
• People who would need a stent placed across or within 0.5 cm of the point where the superficial femoral and deep femoral arteries meet
• People whose procedure is planned in advance to require placing one stent inside another already-existing stent (such as for in-stent restenosis)
• People whose artery is too twisted or difficult to access, or has bends of 90 degrees or more that would prevent the stent device from being delivered safely
• People who would need a stent placed within 1 cm of a stent that was placed in a previous procedure
• People whose procedure involves the use of plaque-removing (atherectomy) or other tissue-destroying devices such as cryoplasty
• People who had a prior treatment to the target area using atherectomy, laser, or cryoplasty within the 3 months before this procedure, where re-narrowing has occurred
• People with serious tissue damage or wounds in the affected limb, classified as Rutherford-Becker category 5 or 6
• People whose procedure would require two stents to be placed overlapping each other
• People who had a heart procedure within 7 days before, or have one planned within 30 days after, the target treatment
• People who had a stroke within 30 days before the procedure
• People with known allergies to aspirin, certain blood-thinning medications, heparin or similar drugs, the metal used in the stent (nitinol/nickel titanium), certain polymer or drug coatings used on the device, or contrast dye used during imaging — where the allergy cannot be medically managed
• People who have been receiving dialysis or immune-suppressing medication within the 30 days before the procedure
• People with a known or suspected active infection anywhere in the body at the time of the procedure
• People with a known bleeding disorder, a condition causing the blood to clot too easily, or severe anaemia (haemoglobin below 8.0) that cannot be corrected
• People with a very low platelet count (below 50,000/μL)
• People with an INR blood clotting result above 1.5 (confirm with trial site)
• People with significantly reduced kidney function, measured as a GFR below 30 ml/min using a standard calculation method (confirm with trial site)
• People with a serious ongoing illness that means their life expectancy is estimated to be less than one year
• People whose procedure is planned to include the use of a drug-coated balloon
• People who are pregnant, or people of childbearing potential who do not have a documented negative pregnancy test within 7 days before enrolment
• People who are currently taking part in another clinical study that has not yet completed its main measurement phase

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