Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

Summary

The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions.

Study Stents:

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model

Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation

Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation.

To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.

Conditions

• Ischemic Heart Disease

Interventions

DEVICE

Stent

Stent implantation

DEVICE

Stent

Stent implantation

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

  collaborator INDUSTRY

• Medtronic Vascular

  lead INDUSTRY

Principal Investigators

• Edoardo Camenzind, MD · University of Geneva, Switzerland

• Laura Mauri, MD · Brigham and Women's Hospital, US

• William O'Neill, MD · University of Miami Miller School of Medicine, US

• Prof. Patrick W. Serruys, MD, PhD · Erasmus Medical Center

• Prof. Philippe Gabriel Steg, MD, PhD · Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France

• William Wijns, MD, PhD · O.L.V. Hospital, Aalst, Belgium

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2012-05-31

Completion

2014-07-31

Countries

• Netherlands

Study Locations