Temsirolimus for Peripheral Artery Disease Below the Knee
This study is testing if a drug called Temsirolimus, delivered directly to the artery wall, can improve outcomes for people with Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI) in their legs below the knee. PAD and CLI can cause blockages in blood vessels. The study compares Temsirolimus to a saline placebo. Researchers want to see if Temsirolimus can reduce the need for further procedures or amputations. You may be eligible if you are 18 or older and have symptomatic PAD (Rutherford 3-5). The study aims to enroll 250 participants, but its current status is unclear.
- Study design
- This is a multicenter, randomized, double-blind, placebo-controlled study involving approximately 250 participants. Participants will be randomly assigned to receive either Temsirolimus or a saline placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after their initial procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Freedom from Cinical Relevant Target Lesion Failure6 Months
Superiority of treatment vs. control group in the composite freedom from the following: * Clinically Relevant Target Lesion Occlusion * Clinically Driven Target Lesion Revascularization * Ischemia-Driven Major Amputation of the Target Limb
- MALE + POD30 Days
Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)