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

NCT00617084 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2292

Last updated 2014-06-06

Study results available
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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.

Conditions

Interventions

DEVICE

Medtronic Endeavor Resolute

Medtronic Endeavor Resolute

DEVICE

Abbott Xience V

Abbott Xience V

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    collaborator INDUSTRY

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • Patrick Serruys, MD · Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands

  • Sigmund Silber, MD · Kardiologische Praxis und Praxisklinik, Munich, Germany

  • Stephan Windecker, MD · University Hospital Bern, Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-05-31
Completion
2014-02-28

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617084 on ClinicalTrials.gov