Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
NCT00715884 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 678
Last updated 2014-01-20
Summary
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.
Conditions
- Coronary Artery Disease
- Coronary Atherosclerosis
Interventions
- DEVICE
-
CYPHER® ELITE™ Sirolimus-Eluting Stent System
Drug eluting stent
- DEVICE
-
CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
Drug eluting stent
Sponsors & Collaborators
-
Cordis Corporation
lead INDUSTRY
Principal Investigators
-
Lowell Satler, MD · Medstar Health Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2010-03-31
- Completion
- 2014-09-30
Countries
- United States
Study Locations
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