Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
NCT00283413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 514
Last updated 2009-11-02
Summary
The objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein bypass graft disease.
Conditions
- Symptomatic Ischemic Saphenous Vein Graft Disease
Interventions
- DEVICE
-
Covered Stent System
Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
- DEVICE
-
Bare metal stent
Any commercially available bare metal stent for coronary indication
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Mark Turco, MD · Washington Adventist Hospital, Takoma Park, MD
-
Maurice Buchbinder, MD · Foundation for Cardiovascular Medicine, La Jolla, CA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-03-31
- Primary Completion
- 2004-05-31
- Completion
- 2009-03-31
Countries
- United States
- Canada
Study Locations
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