Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent

NCT ID: NCT00617084

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2014-02-28

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1. Resolute

Medtronic Endeavor Resolute

Group Type: ACTIVE_COMPARATOR

Medtronic Endeavor Resolute

Intervention Type: DEVICE

Medtronic Endeavor Resolute

2. XIENCE V

Abbott Xience V

Group Type: ACTIVE_COMPARATOR

Abbott Xience V

Intervention Type: DEVICE

Abbott Xience V

Interventions

Medtronic Endeavor Resolute

Medtronic Endeavor Resolute

Intervention Type: DEVICE

Abbott Xience V

Abbott Xience V

Intervention Type: DEVICE

Other Intervention Names

Endeavor Resolute Zotarolimus-Eluting Coronary Stent System; XIENCE V Everolimus Eluting Coronary Stent System

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: collaborator

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Serruys, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands

Sigmund Silber, MD

Role: PRINCIPAL_INVESTIGATOR

Kardiologische Praxis und Praxisklinik, Munich, Germany

Stephan Windecker, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bern, Bern, Switzerland

Locations

Stiftung Inselspital, Department of Cardiology

Bern, , Switzerland

Countries

Switzerland

References

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Other Identifiers

Version 1.2 - IP090

Identifier Type: -

Identifier Source: org_study_id