Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
NCT00140101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1099
Last updated 2012-01-10
Summary
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that has proven superior to bare metal stents and is a recognized standard of care.
Conditions
- Coronary Disease
- Coronary Artery Disease
- Coronary Restenosis
Interventions
- DEVICE
-
ZoMaxx™ Drug-Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
- DEVICE
-
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Alan Yeung, M.D. · Stanford University
-
David Lee, M.D. · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2007-09-30
- Completion
- 2012-01-31
Countries
- United States
- Australia
- Germany
- New Zealand
Study Locations
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