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 18 or older.
• People who are considered legally able to make their own decisions, have been fully informed about the study, and have voluntarily signed a consent form.
• People whose leg artery disease falls within a moderate-to-moderately-severe range of symptoms, known as Rutherford Category 2–4 (confirm with trial site).
• People who have a long blocked or re-narrowed artery segment (at least 10 cm long) in the target area that has not previously had a stent placed there, and where stent placement is considered a suitable treatment option.
• People whose blocked artery can also be treated with a drug-coated balloon (DCB) or a standard balloon (POBA) as part of the procedure.
• People whose target artery measures between 4.0 and 7.0 mm in diameter and is compatible with the available device sizes.
• People who have at least one open artery running from the treatment area down to the ankle, with no significant narrowing (less than 50% blockage confirmed by imaging).
• People who have not had any other vascular procedures (including on the opposite leg) within 2 weeks before or planned within 30 days after this treatment — with a specific exception allowed for a certain type of prior groin artery repair at least 2 cm away from the treatment site.
• People who are female and of childbearing potential must have had a negative pregnancy test (urine or blood) within 7 days before the procedure.
• People whose blocked artery starts at least 1 cm below a specific point in the upper thigh artery and within a defined section of the artery behind the knee (confirm with trial site for exact location details).

Who may not be able to join:

• People who are pregnant, breastfeeding, planning to become pregnant, or men who are planning to father children.
• People for whom stents, drug-coated balloons, or standard balloons are medically unsuitable based on current device guidelines.
• People with a life expectancy of less than one year.
• People who are unable to take the required blood-thinning medications, or who have a known allergy or sensitivity to contrast dye, nickel, titanium, or tantalum that cannot be adequately managed with medication.
• People for whom the treating team plans to also treat outflow artery disease (arteries below the treatment zone) during the same procedure.
• People for whom laser treatment, atherectomy (plaque removal), or cryoplasty (freezing treatment) is planned during the procedure.
• People whose artery blockage came on suddenly, or who have a recent or developing blood clot in the target artery.
• People who have had a stroke within the past 3 months.
• People who have had a heart attack, clot-dissolving treatment, or chest pain episodes within 2 weeks before enrolling.
• People currently taking part in another clinical trial of an investigational drug or device, or who have previously enrolled in this same study.
• People who, in the opinion of the trial doctor, have another medical condition that may make it difficult to follow the study requirements or may affect the reliability of the results.
• People who already have a stent placed in the target artery or at the target blockage site.

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