NCT00476957

Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8,709 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Stent	Stent implantation
DEVICE	Stent	Stent implantation

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-05-01
• Completion: 2014-07-01
• First posted: 2007-05-22
• Last updated: 2014-11-10
• Results posted: 2014-03-17

Locations

1 site across 1 country: Netherlands