Randomized, Two-Arm, Non-Inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent - Full Text View

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00617084

Purpose

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

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Everolimus

U.S. FDA Resources

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

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Composite of Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization (TLR; clinically indicated) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
1. Resolute: Active Comparator Medtronic Endeavor Resolute	Device: Medtronic Endeavor Resolute Medtronic Endeavor Resolute
2. XIENCE V: Active Comparator Abbott Xience V	Device: Abbott Xience V Abbott Xience V

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minimal age 18 years
Symptomatic coronary artery disease
Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
Presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent.

Exclusion Criteria:

Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material
Participating in other trial before reaching primary endpoint
Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617084

Locations

Switzerland
Stiftung Inselspital, Department of Cardiology
Bern, Switzerland, CH-3010

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

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

More Information

No publications provided

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

Keywords provided by Medtronic Bakken Research Center:

Drug Eluting Stents
Interventional Cardiology

Study placed in the following topic categories:

Everolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Immunologic Factors
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Immunosuppressive Agents
Coronary Artery Disease

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009