Clin2
NCT06122974Possibly a fitNot yet recruiting

Drug-coated stent vs balloon for leg artery blockages

Critical Limb Ischemia

Part of Heart & circulation clinical trials.

This trial compares a new type of stent that slowly releases medication to standard balloon angioplasty for improving blood flow in the leg arteries below the knee. It is for people with severe leg pain at rest or non-healing foot wounds due to critical limb ischemia, aiming to save the limb and improve symptoms.

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

Phase
N/A
Enrollment
518 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You are 18 years or older and are willing to commit to 5 years of follow-up.
  • You have had symptoms of poor blood flow in your leg for more than 2 weeks, such as pain at rest or a non-healing wound on your foot.
  • Imaging shows a blockage in one of the arteries below the knee, with the narrowed area being at least 70% blocked and treatable.
  • The blocked artery in your leg is about 2.5 to 4.25 mm wide, which is a typical size for this treatment.
  • If you have wounds on your foot, they must be confined to the foot and not on the heel or in the bone beyond the toes.
  • You have not had a previous bypass surgery on the same vessel, and you have not been treated for the same blockage within the last 3 months.
  • You can tolerate blood-thinning medications and do not have active infections, kidney failure needing dialysis, or severe heart failure.

View the official record on ClinicalTrials.gov

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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