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Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization — TAP-DANCE  

Peripheral Arterial Disease Clinical Trial

Official title:
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Clinical Trial Summary

This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudication (Rutherford 2-3) or critical limb ischemia (CLI) with rest pain (Rutherford 4). Subjects will be followed for up to 60 months post index procedure.

Clinical Trial Description

To begin to assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of temsirolimus or temsirolimus with dexamethasone in maintaining luminal patency and composite safety endpoints in patients with clinical evidence of moderate to severe claudication or critical limb ischemia with rest pain after revascularization of one or more angiographically significant lesion(s) in superficial femoral or popliteal arteries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03942601
Study type Interventional
Source Mercator MedSystems, Inc.
Contact Kirk Seward, PhD
Phone (510) 614-4555
Email kseward@mercatormed.com
Status Recruiting
Phase Phase 2
Start date October 1, 2019
Completion date August 15, 2024
View Details
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