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NCT07359807Possibly a fitNot yet recruiting

Comparing two balloon treatments for leg artery blockages

Popliteal Artery DiseaseSuperficial Femoral Artery Disease

Part of Heart & circulation, Injuries & trauma clinical trials.

This trial tests a new balloon coated with sirolimus (a drug that helps keep arteries open) against an existing balloon coated with paclitaxel for treating severe blockages in the thigh and knee arteries. It aims to find a better option for improving blood flow and reducing the need for repeat procedures.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
478 people
Ages
21 years and older
Study type
Interventional

Who can take part

  • You are 21 years or older.
  • You have leg pain or symptoms that limit walking (Rutherford category 2-4).
  • You have a new or returning blockage in the thigh or behind-the-knee artery that is at least 70% blocked and has not been treated with a stent before.
  • The blockage is between 1.6 and 7.9 inches long, and the artery is between 4 and 7 mm wide.
  • You have good blood flow in the lower leg arteries (no significant blockages below the knee).
  • You have not had major surgery or a stent placed in the affected leg before.

View the official record on ClinicalTrials.gov

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Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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