Peripheral Arterial Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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 have a significant narrowing (70% or more) or blockage in one or more arteries in the hip, thigh, knee, or lower leg area, in either a new or previously treated area, that a doctor determines is suitable for a balloon procedure.
- People whose artery narrowing or blockage can be treated using one of the specific balloon devices used in this trial (AcoArt Orchid, AcoArt Tulip, or AcoArt Litos), according to the device instructions.
- People who have given written consent before joining, understand the purpose of the study, and agree to attend all required check-ups and follow-up appointments.
- People whose leg circulation problems fall within a specific severity range known as Rutherford Category 2 through 6 — with Category 2 applying only to those who have already tried non-surgical treatments without improvement.
- People who have had any blockages further up the artery (closer to the heart) treated before the main procedure in this trial takes place.
Who may not be able to join:
- People whose leg circulation problems fall into the mildest categories (Rutherford Category 0 or 1), meaning they have little to no symptoms.
- People who are already enrolled in another research study that could affect the results of this trial.
- People who are unable to take the required blood-thinning or anti-clotting medications.
- People who have a severely hardened (calcified) blockage that cannot be opened with a balloon procedure.
- People who have a known allergy or sensitivity to any part of the balloon device used in this trial.
- People who have an untreated fresh or recent blood clot in the artery being treated.
- People with a life expectancy of less than one year.
- People who are pregnant, breastfeeding, or are of childbearing potential and are not using adequate contraception.
- People with other serious health conditions that, in the treating doctor's opinion, may affect how long they live or whether they can reliably attend follow-up appointments.
- People who have had a heart attack or stroke within the 30 days before the procedure.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Schmidt Andrej, Department of Angiology, University Hospital Leipzig
Phone: +49-341-97
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Primary efficacy endpoint - non-CLI group; Primary efficacy endpoint -CLI group; Primary safety endpoint- non-CLI group; Primary safety endpoint- CLI group
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.