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:
- The person joining (or their legal representative) must be willing and able to sign a consent form that has been approved by the relevant ethics review board.
- People who are 22 years of age or older at the time of signing the consent form.
- People who have a blockage or narrowing in the arteries of the lower leg (below the groin) that is suitable for treatment with a specific medical device called the Rotarex™ system, based on the device's official guidelines.
- People whose leg circulation problems fall within certain severity ranges — either a moderate-to-severe chronic (long-term) reduction in blood flow to the limb, or a mild-to-moderate sudden (acute) loss of blood flow to the limb (confirm with trial site for exact classification).
- People whose artery blockage can be crossed through the inside of the vessel using a thin guidewire.
- People who have at least one open, unobstructed artery that supplies blood to the foot, with no major narrowing (less than 50% blockage confirmed by imaging) — this applies only to those with chronic long-term limb circulation problems, not those with sudden acute cases.
Who may not be able to join:
- People who are unwilling or unable to attend follow-up appointments and complete the required check-ins during the study.
- People whose affected artery is narrower than 3 mm in diameter.
- People who are already participating in another clinical trial for a device or drug that could interfere with this study's results.
- People whose treatment plan involves using a different clot-removal or plaque-removal device other than the Rotarex™ system.
- People whose life expectancy is less than one year.
- People who are pregnant, planning to become pregnant during the study, or currently breastfeeding.
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: Prakash Krishnan, MD, FACC, The Icahn School of Medicine, The Mount Sinai Health System
Phone: 19014578360
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
Procedural Success; Freedom from major complications
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.