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 90 years old.
• People who agree not to take part in any other trial involving an investigational drug or device for at least six months after the procedure (non-invasive studies or questionnaire-based studies are allowed).
• People who provide written consent to participate before any study procedures begin, or who have a legally authorised representative provide this on their behalf.
• People who have significant leg pain when walking (claudication) or serious circulation problems that threaten the limb, classified as Rutherford-Becker categories 3 to 5 (confirm with trial site).
• People who agree to attend all required follow-up visits, including follow-up imaging procedures.
• People who have a suitable blood vessel in the groin area (either on the opposite leg or from the same leg going forward) that can be used to access the treatment site — access through the wrist or foot is not allowed.
• People who have up to three blockages or re-narrowed areas in the arteries below the knee, each causing more than 70% narrowing as seen on imaging.
• People whose blockages are located in the upper two-thirds of the arteries below the knee, and at least 10 cm above the ankle joint.
• People whose target blood vessel diameter measures between 2.5 and 3.5 mm on specialised ultrasound imaging.
• People whose blockage length and number falls within the specific limits that allow placement of the trial's scaffold devices (confirm with trial site for exact size combinations allowed).
• People whose blockages, if there are two separate ones, have a gap of at least 2 cm of clear artery between them.
• People whose most deeply located blockage can be successfully crossed with a guidewire from above.
• People whose blockage can be adequately opened with a balloon before the scaffold is placed, achieving less than 50% remaining narrowing on imaging.
• People who have any significant blockages in the arteries above the knee (greater than 50% narrowing) that are successfully treated before the main procedure.
• People who have at least one fully open artery below the ankle in the treated leg, without significant blockages.

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant within six months after the procedure.
• People with other serious health conditions, or social or psychological factors — such as a history of substance misuse — that the investigating doctor believes could prevent full participation or follow-up, including people who have had a symptomatic COVID-19 infection in the past two months or a positive COVID-19 test without symptoms in the past month.
• People who are not legally able to make their own decisions or who are unable to manage their own affairs.
• People with a life expectancy of less than one year.
• People who are not able to walk at all.
• People who have previously had a major amputation of either leg or arm.
• People with advanced kidney disease (stage 4 or above) or who require dialysis.
• People with a known allergy or medical reason to avoid the materials used in the device or the medications required for the study, including anti-clotting medications or contrast dye used in imaging, if that reaction cannot be adequately managed beforehand.
• People who have a surgery or procedure planned within six months after the procedure that would require stopping anti-clotting medications.
• People who have an active infection anywhere in the body.
• People who have had a stroke or heart attack within the three months before the procedure.
• People who have bone infection, gangrene above the toe joints, large areas of tissue loss, a deep heel ulcer, or ulcers caused purely by nerve damage.
• 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 with poorly controlled diabetes, with an HbA1c blood sugar marker above 10%.
• People with a Body Mass Index (BMI) below 18.
• People who have had a procedure to open or bypass the target blood vessel within the past three months.
• People who have any other surgical or vascular procedure planned within 30 days (a planned minor amputation is an exception).
• People whose target blood vessel has other significant blockages further down the vessel.
• People whose blockage cannot be successfully opened with a balloon before the scaffold is placed.
• People whose blockage is at a point where the artery splits into two branches and both branches would need to be treated with a scaffold.
• People who have an aneurysm (bulging of an artery) or a fresh blood clot in the aorta or the arteries of the lower limbs.
• People who have previously had a bypass graft surgery below the knee in the leg being treated.
• People who have previously had a stent placed in the target blood vessel.

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