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 21 years or older (minimum age may vary depending on the US state)
• People who have a serious reduction in blood flow to a limb causing rest pain (a condition classified as Rutherford class 4), with a documented wound, ischaemia, and foot infection (WIfI) score, making up no more than 30% of the total trial participants
• People who have tissue loss or gangrene in the target limb (classified as Rutherford class 5 or 6), with a documented WIfI score
• People whose blocked or narrowed artery in the lower leg meets specific size and location requirements confirmed during the procedure — including blockages or narrowings greater than 50% in the upper portion of the arteries below the knee, between 2 and 20 cm in length (confirm with trial site)
• People whose target artery has been confirmed during the procedure to have acceptable blood flow continuing into a named artery in the foot (confirm with trial site)

Who may not be able to join:

• People whose other health conditions mean their life expectancy is one year or less
• People currently taking part in another clinical trial of an investigational drug or device that has not yet reached its first main result
• People who are breastfeeding, pregnant, or planning to become pregnant during the study
• People whose tissue damage is so extensive that it would only be treatable with complex foot reconstruction or a non-standard amputation through the foot bones — this includes conditions such as: bone infection at or above the base of the toe bones; gangrene affecting the sole, middle, or heel of the foot; deep or large wounds (greater than 3 cm) on the sole, middle, or heel of the foot; full-thickness heel wounds with or without involvement of the heel bone; any wound involving the heel bone; wounds considered to be caused by nerve damage or poor circulation rather than blockage; wounds needing flap surgery or complex management for large areas of tissue loss; or full-thickness wounds on the top of the foot with exposed tendon or bone
• People who have previously had bypass surgery on the target artery
• People for whom a major amputation of the target limb is already planned
• People who have a previously implanted stent in the target artery segment
• People classified as vulnerable or legally protected adults
• People with a bleeding disorder or another condition (such as stomach ulcers) that would prevent the use of required blood-thinning medications
• People with a known allergy to the drug sirolimus
• People with severe (Stage 4) kidney disease, defined as an estimated kidney filtration rate below 30
• People whose artery blockage cannot be crossed with a guide wire during the procedure
• People whose artery blockage extends beyond the ankle joint
• People in whom a residual narrowing of 30% or more remains after initial treatment during the procedure
• People whose blockage requires treatment from a backward (retrograde) access approach — note that a retrograde wire crossing technique is allowed, but the actual treatment must be delivered from the forward (antegrade) direction
• People who require certain other devices at the target site during the procedure, including commercially available drug-coated balloons, bare metal stents, drug-eluting stents, specialty balloons, or atherectomy devices (non-compliant balloons are not considered specialty balloons for this purpose)

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