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| Sponsor: | Medtronic Vascular |
|---|---|
| Information provided by: | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT00217269 |
Purpose
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 |
|---|---|
|
Coronary Artery Disease |
Device: Coronary Artery Stenting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
Endeavor Drug Eluting Stent
|
Device: Coronary Artery Stenting
Endeavor Drug eluting stent
|
|
Active Comparator: 2
Taxus Drug Eluting Stent
|
Device: Coronary Artery Stenting
Taxus Drug Eluting Stent
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | K. Bogdanovich, Medtronic Cardiovascular |
| ClinicalTrials.gov Identifier: | NCT00217269 History of Changes |
| Other Study ID Numbers: | IP060 |
| Study First Received: | September 14, 2005 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Restenosis |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |