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Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee — TANGO-3  

Peripheral Artery Disease Clinical Trial

Official 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

Clinical Trial Summary

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. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

Clinical Trial Description

After completion of revascularization therapy and any decision to place stents, participants will be qualified for final enrollment in the study and will be randomized 1:1 and treated with the investigational drug or placebo. Any stents will be placed only after randomization, assignment, and adventitial drug therapy, although any stenting decisions (other than for treatment of AEs) must be made prior to randomization and adventitial drug delivery in order to avoid bias toward or against stenting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04433572
Study type Interventional
Source Mercator MedSystems, Inc.
Contact Kirk Seward, PhD
Phone (510) 614-4555
Email kseward@mercatormed.com
Status Not yet recruiting
Phase Phase 3
Start date December 1, 2020
Completion date December 1, 2025
View Details
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