Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217269
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2005-09-14
Brief Title:
The ENDEAVOR IV Clinical Trial A Trial of a Coronary Stent System in Coronary Artery Lesions
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 Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2012-04
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 IV
Brief Summary:
The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter RVD of 25-35 mm
Detailed Description:
The ENDEAVOR IV Trial is a prospective multi-center randomized two-arm single-blind trial that will enroll a total of 1548 patients at up to 80 sites in the US The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 25-35 mm
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