Drug-coated balloon for leg artery blockages below the knee
Part of Heart & circulation clinical trials.
This trial tests a special balloon coated with sirolimus (a drug that helps prevent arteries from re-closing) versus a standard balloon for opening blocked arteries below the knee in people with severe leg pain or foot wounds. The goal is to see if the drug-coated balloon works better to keep the artery open longer.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are at least 21 years old.
- You have severe leg pain at rest or wounds/gangrene on your foot or leg (Rutherford class 4, 5, or 6, with a WIFI score).
- A blockage in one of the arteries below the knee (in the calf or foot) that is 0.8 to 8 inches long.
- No major wounds that are deeper than 1.2 inches or that involve bone, and no gangrene on the bottom of your foot or heel with bone involvement.
- No previous bypass surgery or stent in the same leg artery that will be treated.
- You do not have severe kidney disease (eGFR less than 30) or allergy to sirolimus.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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