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 (depending on local rules where the trial is being conducted)
• People with a life expectancy of at least one year
• People who have a serious, long-standing reduction in blood flow to a limb, classified as Rutherford category 4 (rest pain) or category 5 (minor tissue loss), with symptoms lasting more than two weeks
• People who are willing and able to sign a consent form and attend all required follow-up visits
• Women who could potentially become pregnant must not be breastfeeding and must have a negative pregnancy test taken within seven days before the procedure
• People whose blocked artery or arteries are located in the lower leg, below the knee and above the ankle joint, in specific vessels including parts of the popliteal artery and the tibial and peroneal arteries
• People whose blocked artery sections are not directly connected to other problem areas higher up in the leg, with at least 3 cm of normal artery between them
• People whose target artery blockage is at least 70% narrowed (including complete blockages), as estimated visually on imaging
• People whose target artery is between 2 mm and 4 mm wide
• People where all the blockages being treated are within a single target artery (though other arteries with blockages may be enrolled if those other blockages have already been successfully treated separately)
• People where the total length of blockages being treated is at least 30 mm and no more than 140 mm in combined length
• People where the artery beyond the blockage is either open, reconnects above the ankle, or shows normal branching at its end — depending on which artery is being treated (confirm with trial site for your specific artery)
• People who either have no significant narrowing in the larger arteries above the knee feeding blood into the leg, or where any such narrowing has already been successfully treated
• People where the target blockage has been successfully prepared with a balloon or other tool before the trial treatment begins, with less than 30% narrowing remaining and no complications

Who may not be able to join:

• People with severe tissue loss (Rutherford category 6) at or above the base of the toes that would need complex reconstruction or major amputation, including bone infection above the toe joints, any heel wounds or wounds involving the heel bone, wounds needing flap surgery or complex management for large soft tissue loss, or full-thickness wounds on the top of the foot exposing tendon or bone
• People with severe long-term kidney disease (on dialysis, or with a kidney filtration rate of 30 or below within the past 30 days), or people who have had a kidney transplant
• People with sudden kidney failure shown by a 50% rise in a kidney marker (creatinine) within 48 hours before the procedure, or a significant drop in urine output
• People whose limb symptoms began less than two weeks before the procedure (acute rather than chronic)
• People whose wounds are caused by nerve damage or poor vein function rather than poor blood flow, or who have mixed or vein-related wounds
• People who have already had a major amputation of the affected leg, or where a major amputation of either leg is planned
• People who have had a bypass surgery involving the hip or groin artery of the affected leg within the past six weeks
• People who have had another procedure in the blood vessels within the past 14 days, or have one planned within the next 30 days (some exceptions apply, including treatment of blood flow problems in the same leg during the trial procedure, treatment of the opposite leg's hip artery, a diagnostic scan, wound cleaning, or planned removal of a toe at the toe joint — confirm exceptions with trial site)
• People whose target blockage has been treated with a drug-coated balloon within the past year, or has ever been treated with a drug-eluting or bare metal stent (unless the blockage is at least 30 mm away from the stent and the stent has 30% or less narrowing)
• People whose target blockage would need treatments such as clot-dissolving therapy, clot removal, stenting, or a re-entry device (some lesion preparation tools are permitted — confirm with trial site)
• People who need the procedure to be performed through access points in the foot or arm
• People who have had any non-heart artery treatment using a limus-type drug-coated balloon, drug-eluting stent, or similar device within the past three months
• People with a known allergy or serious reaction to sirolimus or other medications needed for the procedure (such as contrast dye, heparin, or bivalirudin) that cannot be managed with pre-treatment
• People who cannot take antiplatelet medications (blood-thinning tablets)
• People who have had a severe stroke or a major heart attack within the past three months
• People currently experiencing an unstable heart condition (stabilised cases may be eligible — confirm with trial site)
• People whose artery disease is not caused by hardening of the arteries — for example, those with artery swelling (aneurysm), inflammatory artery disease (vasculitis), or Buerger's disease
• People with a blood clotting disorder or abnormally low platelet count (100,000 or below per microlitre)
• People with an active whole-body infection shown by a high white blood cell count and fever (enrolment may be possible after the infection has been successfully treated — confirm with trial site)
• People who are known to have a weakened immune system (for example, due to HIV or lupus) or are taking immune-suppressing medications (topical steroid creams are permitted)
• People currently receiving cancer treatment including surgery, chemotherapy, or radiation, or who have cancer that has spread to other parts of the body (local application of chemotherapy creams is permitted)
• People with the most severe level of heart failure (New York Heart Association class IV)
• People who are bedridden
• People with a body mass index (BMI) below 18
• People currently taking part in another clinical trial of an unapproved drug or device that has not yet completed its main follow-up phase
• People with other physical, medical, social, or psychological conditions that in the opinion of the trial doctor would affect their ability to safely participate or attend follow-up visits
• People who have a previously placed stent in the target artery, unless the target blockage is at least 30 mm away from the stent and the stent has 30% or less narrowing
• People with more than 50% narrowing in the main groin arteries (common femoral or profunda femoris), as treatment of these arteries is not permitted in this trial
• People where the target blockage could not be successfully prepared beforehand (more than 30% narrowing remaining, or complications such as a tear or debris travelling downstream after the preparation step)
• People found to have blood clots or debris travelling in the arteries of the affected leg at the time of the initial imaging scan or after pre-treatment
• People who need treatment in the arteries below the ankle joint

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