Clin2
NCT04433572Possibly a fitRecruiting

Temsirolimus treatment to improve below-knee artery procedures

Peripheral Artery DiseaseCritical Limb Ischemia

Treatments studied

Part of Heart & circulation clinical trials.

This trial studies whether delivering a medicine called temsirolimus directly into the artery during a below-knee revascularization procedure can improve blood flow and outcomes. It may help people with severe leg artery disease who have symptoms like pain while walking or threatened limb tissue loss.

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

Phase
Phase 3
Enrollment
250 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You can sign consent and understand the study, and you’re able to attend follow-up visits.
  • You are 18 or older, and if you can become pregnant, you will use highly effective birth control for 90 days after treatment.
  • You have severe leg symptoms from poor circulation: either severe claudication (Rutherford 3) or chronic limb-threatening ischemia (Rutherford 4–5).
  • Your blocked vessel is in the below-knee area (tibial/peroneal or below-knee popliteal), and the blockage fits specific size and location measurements.
  • Your procedure must successfully open the artery with good blood flow to the foot, and no major complications after treatment.
  • You have no major reasons to be excluded, such as recent major blood vessel procedures, life expectancy under 1 year, major infection, certain blood test problems, or inability to receive temsirolimus or contrast dye.

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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