Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476957
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2007-05-21
Brief Title:
Randomized Study Comparing Endeavor With Cypher Stents PROTECT
Sponsor:
Medtronic Vascular
Organization:
Medtronic Vascular
Study Overview
Official Title:
PROTECT Trial Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
Brief 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 andor vessel- or lesion characteristics
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 andor vessel- or lesion characteristics
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None