Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
- Conditions
- Peripheral Arterial Disease
- Interventions
- Registration Number
- NCT03942601
- Lead Sponsor
- Mercator MedSystems, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 - temsirolimus injection Temsirolimus Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1 Group 2 - temsirolimus and dexamethasone injection Temsirolimus and dexamethasone sodium phosphate Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2
- Primary Outcome Measures
Name Time Method Safety - Freedom from MALE-POD at 30 days 30 days post intervention Freedom from MALE-POD at 30 days
Effectiveness - Primary patency 12 months post intervention Primary patency (adjudicate by angio core lab)
Effectiveness - Freedom from CD-TLR 12 months post intervention Freedom from clinically driven target lesion revascularization (CD-TLR)) at 12 months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
St. Joseph Hospital of Orange Heart and Vascular Center
🇺🇸Orange, California, United States
Rocky Mountain Veterans Administration Hospital
🇺🇸Denver, Colorado, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University Hospital
🇺🇸Cleveland, Ohio, United States
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
North Carolina Heart and Vascular
🇺🇸Raleigh, North Carolina, United States