Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
Stopped early · Phase 2
Conditions studied: Peripheral Arterial Disease
In brief
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.
Key facts
- Study ID
- NCT03942601
- Run by
- Mercator MedSystems, Inc.
- People needed
- 10
- Starts
- 2019-10-01
- Expected to finish
- 2021-04-30
- Last updated by the study team
- 2024-07-10
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- St. Joseph Hospital of Orange Heart and Vascular Center — Orange, California, United States
- San Francisco VA Medical Center — San Francisco, California, United States
- University of Colorado — Denver, Colorado, United States
- Rocky Mountain Veterans Administration Hospital — Denver, Colorado, United States
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States
- Columbia University Medical Center/NYPH — New York, New York, United States
- North Carolina Heart and Vascular — Raleigh, North Carolina, United States
- University Hospital — Cleveland, Ohio, United States
- Einstein Medical Center — Philadelphia, Pennsylvania, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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