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Sponsored by: |
Medtronic Bakken Research Center |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00617084 |
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.
Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: Medtronic Endeavor Resolute Device: Abbott Xience V |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | RESOLUTE-III All-Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention |
Estimated Enrollment: | 2300 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. Resolute: Active Comparator
Medtronic Endeavor Resolute
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Device: Medtronic Endeavor Resolute
Medtronic Endeavor Resolute
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2. XIENCE V: Active Comparator
Abbott Xience V
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Device: Abbott Xience V
Abbott Xience V
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The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.
Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.
Study hypothesis: To determine whether the Zotarolimus-Eluting stent (Medtronic Endeavor-Resolute) is non-inferior to the Everolimus-eluting stent (Abbott XIENCE V) in terms of the primary endpoint at 12 months after stent implantation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Stiftung Inselspital, Department of Cardiology | |
Bern, Switzerland, CH-3010 |
Principal Investigator: | Patrick Serruys, MD | Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands |
Principal Investigator: | Sigmund Silber, MD | Kardiologische Praxis und Praxisklinik, Munich, Germany |
Principal Investigator: | Stephan Windecker, MD | University Hospital Bern, Bern, Switzerland |
Responsible Party: | Medtronic Bakken Research Center ( Frank van Leeuwen, MD ) |
Study ID Numbers: | Version 1.2 - IP090 |
Study First Received: | February 4, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00617084 History of Changes |
Health Authority: | Belgium: Institutional Review Board; Denmark: Ethics Committee; France: Institutional Ethical Committee; Germany: Ethics Commission; Ireland: Medical Ethics Research Committee; Israel: Ethics Commission; Italy: Ethics Committee; Netherlands: Medical Ethics Review Committee (METC); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Switzerland: Ethikkommission; United Kingdom: Research Ethics Committee; United States: Food and Drug Administration |
Drug Eluting Stents Interventional Cardiology |
Everolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Immunologic Factors Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Immunosuppressive Agents Coronary Artery Disease |
Arterial Occlusive Diseases Everolimus Heart Diseases Immunologic Factors Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases |
Arteriosclerosis Immunosuppressive Agents Pharmacologic Actions Coronary Disease Cardiovascular Diseases Coronary Artery Disease |