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 who are 18 years of age or older at the time of giving consent
• People who are willing to attend all required follow-up visits and have signed an approved consent form
• Women who could become pregnant must have a negative pregnancy test within 7 days before the procedure and agree to use reliable contraception for the duration of the study (women who are sterile, infertile, or have not had a period for at least 12 months are exempt from this requirement)
• People whose doctor estimates they are expected to live for more than 1 year
• People who have a documented condition called chronic limb-threatening ischemia (seriously reduced blood flow to a limb causing rest pain or wounds) classified at a specific severity level (Rutherford category 4 or 5)
• For people with the more severe classification (Rutherford category 5): wounds, infection, and blood flow must fall within specific ranges on a standard medical scoring system (confirm with trial site)
• People who have not had any other surgical or vascular procedures within 2 weeks before the trial procedure, and have none planned within 30 days after it
• People whose affected blood vessel in the lower leg measures between 2.0mm and 4.0mm in diameter and can be treated with the available device sizes
• People whose affected artery blockage or narrowing (70–100% blocked) measures 190mm or less in total length
• People whose artery blockage is located in the lower leg below the knee and above the ankle joint, within specific boundaries (confirm with trial site)
• People who have at least one clearly visible blood vessel pathway delivering blood to the foot, confirmed by imaging
• People who do not have significant upstream blockages (50% or more) in the arteries feeding the affected area, OR whose upstream blockages were successfully treated before enrolling, with no more than 30% narrowing remaining
• People whose affected artery section can be successfully opened with a balloon procedure before the trial treatment is applied, with no more than 50% narrowing remaining and no serious tears in the artery wall

Who may not be able to join:

• People who have a planned amputation above the base of the toes, or any other major surgery planned within 30 days before or after the procedure (planned amputations at or below the base of the toes are acceptable)
• People who have had a heart attack or stroke within the 30 days before the procedure
• People who have a known or suspected active infection at the time of the procedure, except for a localised, controlled wound infection on the affected leg that falls within an accepted severity range
• People whose wound infection and blood flow scores fall outside specific accepted ranges on the standard medical scoring system (confirm with trial site)
• People who are not able to walk independently
• People who have certain types of foot wounds (nerve-related ulcers, heel pressure wounds, or heel bone ulcers) that carry a risk of major amputation (people with less complicated ulcers may still be considered)
• People who have a documented active bone infection (osteomyelitis) beyond the toe bones that has spread into the bone tissue, based on clinical assessment
• People who have inflammatory conditions such as vasculitis, lupus, or polymyalgia rheumatica and are currently receiving treatment for them
• People with significantly reduced kidney function (eGFR below 30 ml/min) or who are on dialysis
• People currently receiving ongoing steroid treatment at a dose above a certain level (equivalent to more than 5mg of prednisolone per day) expected to continue for the first 9 months after the procedure
• People with known allergies to heparin, aspirin, other blood-thinning medications that cannot be substituted, paclitaxel (a medication used in the trial device), or contrast dye used in imaging that cannot be adequately managed beforehand
• People who are currently enrolled in another clinical trial involving an investigational device, drug, or biological treatment
• Women who are breastfeeding at the time of enrolment
• People with significant gastrointestinal bleeding or a blood-clotting disorder that would make blood-thinning medication unsafe to use
• People with serious other medical conditions (such as severe heart failure, very low heart pumping function, severe lung disease, or cancer that has spread) that would prevent safe participation in the study, or who are currently receiving immune-suppressing, chemotherapy, or radiation treatments
• People whose artery blockage extends below the ankle joint
• People who have untreated significant blockages (50% or more) in the major arteries of the same leg above the target area (hip, thigh, or knee arteries)
• People where a pre-existing upstream blockage could not be successfully reduced to 30% or less narrowing during treatment before the trial procedure
• People who have previously had a stent placed or bypass surgery in the target blood vessel
• People who have had a drug-coated balloon procedure in the target blood vessel within the 6 months before the trial procedure
• People who have an aneurysm (abnormal bulging) in the target blood vessel
• People whose imaging shows a blood clot in the arteries of the affected limb
• People in whom the preparatory balloon procedure caused a serious artery tear or left more than 50% narrowing remaining
• People whose artery condition requires the use of other specialised treatment tools (such as atherectomy devices, scoring balloons, laser, radiation, or stents) as part of treating the target vessel

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