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 who (or whose legal representative) have given written consent before any study procedures begin, using the approved consent form.
• People who agree not to take part in any other clinical drug or device trial for at least 12 months after the procedure (non-invasive questionnaire studies are permitted).
• People who have serious, ongoing reduced blood flow to a limb causing symptoms such as pain at rest or non-healing sores, rated as Rutherford category 4 or 5 (confirm with trial site).
• People who are aged 18 to 90 years old.
• People who agree to attend all required follow-up visits, including imaging scans of the arteries.
• People whose blocked or narrowed artery is located in specific leg arteries below the knee (the tibioperoneal trunk, anterior tibial artery, posterior tibial artery, or peroneal artery).
• People whose blockage is in the upper two-thirds of these below-knee arteries and at least 10 cm above the ankle joint.
• People who have up to two blockages in up to two different arteries, where a guidewire has been successfully passed through all blockages before the study treatment begins.
• People whose arteries beyond the blockage (toward the foot) are sufficiently open and free of major narrowing.
• People who have any significant narrowing in arteries above the knee treated successfully before the study treatment, with good results and no complications.
• People whose target artery measures between 3.0 and 3.5 mm in diameter as seen on imaging.
• People whose blockage is either new (never treated before) or has narrowed again by at least 70% after a previous non-stent treatment (blockages inside existing stents are not eligible).
• People whose total length of all blockages to be treated does not exceed 11 cm in total.
• People whose individual blockage is longer than 14 mm.
• People whose planned scaffold (device) length does not exceed 12 cm and includes at least 2 mm of normal artery on each side of the treated area.
• People whose target artery has no other significant narrowings (50% or more) outside the area being treated.
• People with two separate blockages that have at least 2 cm of normal artery between them, provided the total length of both blockages does not exceed 11 cm.
• People whose treatment area does not block access to major named branch arteries in the lower leg.
• People who have any other below-knee blockages in non-target arteries successfully treated before the study treatment begins, with no complications.
• People who have suitable artery access in the groin area (either from the opposite leg or from the same leg going forward).
• People who have at least one fully open artery below the ankle in the treated leg, without significant narrowing.

Who may not be able to join:

• People with a Body Mass Index (BMI) below 18 (a measure of body weight relative to height).
• People who are pregnant, breastfeeding, or who plan to become pregnant during the follow-up period of the study.
• People whose life expectancy is estimated by the treating doctor to be less than one year at the time of enrolment.
• People who are permanently confined to bed.
• People who have a known allergy or serious reaction to the device materials (including sirolimus, certain plastics, lactic acid, or platinum-iridium), to required medications (including blood-thinning medications), or to contrast dye used in imaging, and who cannot be adequately pre-treated to prevent a reaction.
• People who have a planned surgery or procedure that would require stopping blood-thinning medications within 6 months after the procedure.
• People who have had a procedure to restore blood flow in the target artery within the past 3 months.
• People who have previously had a major amputation of the leg being considered for treatment.
• People who have a planned surgical or artery procedure within 6 months after the study procedure (minor toe or foot amputations are an exception).
• People whose blood flow measurement (ankle-brachial index) shows a reading of 0.39 or higher, indicating the blood flow reduction may not be severe enough (confirm with trial site).
• People whose foot wounds or ulcers are caused by nerve damage alone, with no reduced blood flow involved.
• People who have bone infection, gangrene above the toe joints, large areas of tissue loss with exposed tendons, full thickness heel sores, or purely nerve-related ulcers.
• People with poorly controlled diabetes where a blood sugar marker (HbA1c) is above 10%.
• People who have had a stroke or heart attack within 3 months before the procedure.
• People who have acute kidney failure, severe or end-stage chronic kidney disease (eGFR below 30 mL/min), or who require dialysis.
• People who have an active infection anywhere in the body.
• People who are taking medications that suppress the immune system, or who have a known immune system or autoimmune condition (such as HIV, lupus, or rheumatoid arthritis).
• People who have an active cancer and are receiving or scheduled to receive cancer treatment within one year before or after the procedure, or who have certain blood disorders or abnormal blood counts.
• People who lack the legal or mental capacity to make their own decisions and do not have an authorised representative.
• People who have significant other health, social, or psychological conditions — such as a history of substance abuse — that in the treating doctor's opinion may affect their ability to participate or follow study instructions; this includes people who have had symptomatic COVID-19 in the past 2 months or a positive COVID-19 test in the past month.
• People whose artery imaging shows evidence of clot-related blockages or debris travelling through the arteries in the treated area.
• People who have a significant narrowing in the lower section of the popliteal artery (just above the knee area) that has not been treated or was treated with a certain type of plaque-removal procedure (atherectomy).
• People who have an aneurysm (bulging artery) or a fresh blood clot in the aorta or leg arteries.
• People who have previously had a bypass surgery below the knee in the leg being treated.
• People who have previously had a stent placed in the artery being treated.
• People whose target artery has significant narrowings outside the area allowed for treatment.
• People whose blockages (in the target or other arteries) show severe calcification (hardening) based on a specific imaging classification (PACSS grade 4).
• People in whom the arteries supplying blood to the treated area could not be successfully opened before treatment.
• People who do not have an open artery running continuously to the foot from the treated vessel.
• People whose blockage is located at a fork in the artery where both branches would need to be treated simultaneously with the device.
• People in whom the artery could not be successfully prepared (pre-dilated) before placing the device.
• People for whom a plaque-removal procedure (atherectomy) is planned for any artery being treated.

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