Sirolimus-coated balloon vs standard balloon for leg artery narrowing
Part of Heart & circulation clinical trials.
This trial compares two balloon treatments used during a procedure to open blocked or narrowed arteries in the thigh and behind the knee. It tests whether the sirolimus-coated balloon works better at keeping the artery open than a standard balloon.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Be 21 years or older.
- Have moderate-to-severe poor blood flow in the target leg (Rutherford class 3 to 6).
- Have a specific type of blockage in the thigh/knee arteries (2–20 cm, either new narrowing or previously treated narrowing).
- Before treatment, have good enough blood flow from the upper leg and at least one lower-leg “runoff” vessel to the foot.
- Not be pregnant, and agree not to become pregnant during the study.
- Able to take blood thinners like aspirin and/or clopidogrel (no bleeding disorder or ulcers that prevent this).
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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