Last updated on March 2020

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03942601

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