The COPPER-B Trial
NCT02395744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2017-02-27
Summary
The purpose of the COPPER - B study is to assess the feasibility, safety, and initial efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the OPC.
Conditions
- Cardiovascular Diseases
- Peripheral Vascular Disease
- Arterial Occlusive Diseases
- Peripheral Arterial Disease
- Critical Limb Ischemia
Interventions
- OTHER
-
Paclitaxel administration using the OPC
Sponsors & Collaborators
-
Advanced Catheter Therapies, Inc.
collaborator INDUSTRY -
Horizons International Peripheral Group
lead OTHER
Principal Investigators
-
Frank Bunch, MD, FACC · Cardiology Associates
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-11
- Primary Completion
- 2016-08-15
- Completion
- 2017-02-23
Countries
- United States
Study Locations
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