Drug-coated stent vs balloon angioplasty for critical limb ischemia
Part of Heart & circulation clinical trials.
This trial tests a special drug-coated stent (called a temporary spur stent) against the standard procedure of balloon angioplasty alone, for people with severely blocked arteries in the lower leg that cause pain at rest or minor sores (Rutherford class 4 or 5). The goal is to improve blood flow and prevent amputation.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have chronic (over 2 weeks) severe leg pain at rest or minor tissue loss in the foot or toe
- You have at least one blocked or narrowed artery below the knee that is 70% or more blocked and can be crossed with a wire
- The blocked area is less than 8.3 inches (210 mm) long, and the artery is between 2.5 and 4.25 mm wide
- You are able to take blood thinners (antiplatelet therapy) and have no allergies to the study drugs or materials
- You have not had a heart attack or stroke in the last 90 days, and your kidney function is good (eGFR above 25)
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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