The OPC for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee
NCT02464501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2019-11-08
Summary
The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
Conditions
- Peripheral Arterial Disease
- Cardiovascular Disease
- Peripheral Vascular Disease
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
- 2015-05-20
- Primary Completion
- 2019-09-30
- Completion
- 2019-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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