Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
NCT00287573 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 488
Last updated 2010-08-06
Summary
The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent restenosis.
Conditions
- Coronary Restenosis
Interventions
- DEVICE
-
TAXUS Express2
Paclitaxel-Eluting Coronary Stent System
- PROCEDURE
-
Brachytherapy (beta source)
Brachytherapy (beta source)
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Gregg W. Stone, MD · Columbia University
-
Stephen G. Ellis, MD · The Cleveland Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-06-30
- Primary Completion
- 2004-12-31
- Completion
- 2010-01-31
Countries
- United States
- Canada
Study Locations
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