The Study to Assess AMI Treated With Balloon Angioplasty.
NCT00232830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 715
Last updated 2009-09-16
Summary
The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
Conditions
Interventions
- DEVICE
-
drug-eluting stent
Cypher Sirolimus-eluting Coronary Stent
- DEVICE
-
bare-metal stent
any bare-metal stent brand
Sponsors & Collaborators
-
Cordis Corporation
lead INDUSTRY
Principal Investigators
-
Christian Spaulding, MD · HOPITAL COCHIN, René Descartes University
-
Christoph Bode, MD · University of Freiburg, Albert-Ludwigs-Universitätskliniken
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Primary Completion
- 2009-02-28
- Completion
- 2009-04-30
Countries
- France
- Germany
Study Locations
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