Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from the 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 to 85 years old, of any sex
• People whose blocked or narrowed artery is located in the upper leg artery (superficial femoral artery) or the upper part of the artery behind the knee (proximal popliteal artery)
• People with leg artery narrowing or blockage that causes symptoms rated at a moderate to serious level on a standard medical scale (Rutherford classification 2 to 5), such as leg pain when walking or sores on the leg
• People expected to live for more than one year
• People who have been fully informed about the study and have signed a consent form agreeing to take part
• People whose artery in the target area is narrowed by 70% or more, or is completely blocked over a length of less than 150mm (based on imaging)
• People whose target artery measures between 3mm and 7.5mm wide, with the total length of blocked or narrowed sections measuring between 50mm and 250mm
• People who still have significant narrowing (more than 30%) or a tear in the artery wall after a balloon treatment procedure (called DCB/PTA), meaning a stent may be needed
• People whose artery leading into the treated area is either clear or has been successfully treated, with less than 50% narrowing remaining
• People who have at least one clear artery pathway beyond the treated area (less than 70% narrowed before the procedure)

Who may not be able to join:

• People who have previously had bypass surgery on the target artery, or whose narrowing is occurring inside a previously placed stent
• People with a blood creatinine level above 2.5mg/dl, or who are currently receiving regular kidney dialysis (haemodialysis or peritoneal dialysis)
• People with a serious blood clotting disorder
• People with certain serious blood vessel conditions, including sudden severe leg artery blockage, a serious clotting disorder affecting the whole body, a disease causing blood vessel inflammation (thromboangiitis obliterans), deep vein blood clots, or aneurysms in nearby major arteries
• People with a history of major organ failure or serious illnesses such as severe heart disease, severe heart failure, severe nerve or mental health conditions, or serious gastrointestinal bleeding, or who have had or are planning an organ transplant
• People who had a heart attack or stroke with symptoms in the three months before joining the trial
• People who received clot-dissolving treatment in the target artery within 72 hours before the procedure, where the clot was not fully dissolved
• People with an active infection throughout the body or an uncontrolled infection in the affected leg
• People with a known allergy to contrast dye, nickel or titanium (a metal alloy called Nitinol), heparin, aspirin, clopidogrel, or anaesthetics
• People who are pregnant, breastfeeding, or women of childbearing age who plan to become pregnant within one year
• People who are planned to have a major amputation of the affected leg
• People who have had or are scheduled to have another procedure on the affected leg within 30 days before or after this trial's procedure
• People currently taking part in another clinical trial involving a medical device or drug
• People the trial investigator considers unsuitable for participation for any other reason
• People where a guidewire was unable to pass through the blocked section during the procedure
• People whose procedure involved or was planned to involve certain specialised techniques such as cryogenic angioplasty, laser treatment, or rotational plaque removal
• People whose blockage is caused entirely by a clot in a way that makes stent placement unsuitable
• People whose artery blockage is severely hardened (calcified) and could not be adequately prepared for a stent, or who have the most severe level (grade 4) of calcification
• People with a sudden or very recent complete blockage or blood clot in the target artery
• People who have already had a stent placed in the target artery before joining the trial

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