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 between 18 and 85 years old.
• People who are able to understand the purpose of the trial, are willing to take part voluntarily, sign a consent form, and commit to follow-up appointments over 12 months.
• People who have a serious condition called Critical Limb Ischemia (severely reduced blood flow to a limb causing significant symptoms), classified at a specific level of severity (Rutherford category 3–5) (confirm with trial site).
• People who need their first-ever treatment for a newly developed blockage or narrowing in the arteries below the knee.
• People whose blocked or narrowed artery or arteries below the knee are narrowed by 70% or more, or are fully blocked, in no more than two of those arteries.
• People whose artery problem is located at least 10 cm above the ankle joint.
• People whose artery problem is in the upper two-thirds of the arteries below the knee, spans no more than 200mm in length, and is in a vessel between 2.5 and 4 mm wide.
• People where no more than two arteries below the knee need to be treated at the same time.
• People where no more than two stents are needed in any single target artery.
• People who have at least one artery to the ankle that is mostly clear (less than 30% narrowed).

Who may not be able to join:

• People with severely reduced kidney function, kidney dialysis dependence, or significantly reduced liver function.
• People who have already had a major amputation, or for whom a major amputation is planned.
• People with any condition that affects blood clotting.
• People who have had surgery or clot-dissolving treatment on the same leg within the past 6 weeks.
• People who have had a stroke within the past 3 months, or who had a stroke more than 3 months ago that left severe ongoing effects such as paralysis or difficulty speaking.
• People who have had a heart attack or acute heart-related event within the past 30 days.
• People with a disease called Thromboangiitis obliterans (Buerger's disease), a condition causing blood vessel inflammation.
• People who have received treatment with a drug-coated balloon or drug-coated stent within the past 90 days.
• People who have previously had any procedure on the target artery.
• People who have previously had a procedure to reduce the size or volume of the target artery.
• People who are known to be allergic to aspirin, heparin, clopidogrel, polylactic acid, iron, zinc or its breakdown products, contrast dye, sirolimus, or similar substances — or people who cannot tolerate the blood-thinning medication required after the procedure.
• People with a history of iron overload or iron-related conditions, such as hereditary hemochromatosis.
• People who are currently enrolled in another clinical trial that has not yet reached its main results stage.
• Women of childbearing age who are not using effective contraception, or women who are pregnant or breastfeeding.
• People the trial doctor considers unsuitable for participation for any other reason.
• People whose life expectancy is 12 months or less, as assessed by the trial doctor.
• People who have significant narrowing (more than 30%) in the arteries leading into the leg (such as the iliac, femoral, or popliteal arteries), with or without prior treatment.
• People who have a narrowing or blockage longer than 150mm in the arteries leading into the leg.
• People who have significant narrowing (50% or more) in the arteries beyond the treatment area that the target vessel supplies.
• People who have a previously placed stent that has re-narrowed in any leg artery.
• People who have a blood clot in the target artery, or an acute clot requiring clot-removing treatment.
• People whose guidewire cannot pass through the blocked area during the procedure.
• People whose imaging during the procedure shows that additional surgical techniques (such as rotational atherectomy or laser therapy) would be needed.
• People who have an aneurysm (abnormal bulging) in any leg artery on the same side as the treatment.

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