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Sponsored by: |
Medtronic Vascular |
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Information provided by: | Medtronic Vascular |
ClinicalTrials.gov Identifier: | NCT00217269 |
The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.5-3.5 mm.
Condition | Intervention |
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Coronary Artery Disease |
Device: Coronary Artery Stenting |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions |
Enrollment: | 1548 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | July 2011 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Endeavor Drug Eluting Stent
|
Device: Coronary Artery Stenting
Endeavor Drug eluting stent
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2: Active Comparator
Taxus Drug Eluting Stent
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Device: Coronary Artery Stenting
Taxus Drug Eluting Stent
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The ENDEAVOR IV Trial is a prospective, multi-center, randomized, two-arm, single-blind trial that will enroll a total of 1,548 patients at up to 80 sites in the US. The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 2.5-3.5 mm.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
New York-Presbyterian Hospital/Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Martin B. Leon, M.D. | Columbia University College of Physicians & Surgeons |
Responsible Party: | Columbia University College of Physicians & Surgeons ( Martin B Leon, MD ) |
Study ID Numbers: | IP060 |
Study First Received: | September 14, 2005 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00217269 |
Health Authority: | United States: Food and Drug Administration |
Restenosis |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |