Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217256
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2005-09-14
Brief Title:
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
Sponsor:
Medtronic Vascular
Organization:
Medtronic Vascular
Study Overview
Official Title:
A Randomized Controlled Trial of the Medtronic Endeavor Drug ABT-578 Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2011-06
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:
ENDEAVOR III
Brief Summary:
To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 10 microgramsmm and the Cypher Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries 25-35 mm in diameter
Detailed Description:
The ENDEAVOR III Trial is a prospective multi-center single-blind randomized trial that enrolled 436 patients at 29 sites in the US The purpose of this trial is to demonstrate the equivalency of in-segment late lumen loss at 8 months between the Endeavor stent and the Cypher stent for the treatment of single de novo lesions in native coronary arteries 25-35 mm in diameter Patients were randomized to receive the Endeavor stent or the Cypher Sirolimus-Eluting Coronary Stent System Enrollment was completed in September 2004
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