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Clinical trial

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease

NCT04433572 is registered in ClinicalTrials.gov with Mercator MedSystems, Inc. as lead sponsor.

NCT NCT04433572
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Registry record

As filed in ClinicalTrials.gov.

Title
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease
Lead sponsor
Mercator MedSystems, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
July 30, 2025
Completion date
August 1, 2032
Enrollment
250 (estimated)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

critical limb ischemia, peripheral artery disease