Clin2
NCT04511234Worth exploringRecruiting

Sirolimus-coated balloon vs standard balloon for leg artery narrowing

Peripheral Artery DiseaseAtherosclerosisArterial Disease

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.

Phase
N/A
Enrollment
279 people
Ages
21 years and older
Study type
Interventional

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).

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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