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

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.

Timeline

Start

2019-10-01

Primary completion

2021-04-30

Completion

2021-04-30

Drugs

Indications