First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis
NCT01962389 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2014-12-08
Summary
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
Conditions
- Femoropopliteal In-Stent Restenosis
Interventions
- DEVICE
-
Winsor Laser Catheter
Sponsors & Collaborators
-
Yale University
collaborator OTHER -
Spectranetics Corporation
lead INDUSTRY
Principal Investigators
-
Carlos Mena, MD · Yale University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-04-30
Countries
- Colombia
Study Locations
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