Randomized Study Comparing Endeavor With Cypher Stents (PROTECT) (PROTECT)
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.
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial|
- To Compare Overall Definite or Probable 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 [ Time Frame: 3 years ]Definite or probable stent thrombosis rate.
- Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions [ Time Frame: 3 years ]Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions
|Study Start Date:||June 2007|
|Study Completion Date:||July 2014|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Other Name: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Active Comparator: 2
Cordis Cypher® Sirolimus-eluting Coronary Stent
Other Name: Cordis Cypher® Sirolimus-eluting Coronary Stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476957
|196 enrolling sites Worldwide|
|Principal Investigator:||Edoardo Camenzind, MD||University of Geneva, Switzerland|
|Principal Investigator:||Laura Mauri, MD||Brigham and Women's Hospital, US|
|Principal Investigator:||William O'Neill, MD||University of Miami Miller School of Medicine, US|
|Principal Investigator:||Prof. Patrick W. Serruys, MD, PhD||Erasmus MC, Rotterdam, the Netherlands|
|Principal Investigator:||Prof. Philippe Gabriel Steg, MD, PhD||Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France|
|Principal Investigator:||William Wijns, MD, PhD||O.L.V. Hospital, Aalst, Belgium|