Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165035
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2005-09-09
Brief Title:
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial COSTAR II
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
Multi-Center Single-Blind Two-Arm Randomized Controlled Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries
Status:
COMPLETED
Status Verified Date:
2011-08
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent TAXUS Express2 Paclitaxel-Eluting Coronary Stent in the treatment of single-vessel one blood vessel and multi-vessel two or three blood vessels coronary artery disease
Detailed Description:
Non -inferiority in 8-month Major Adverse Cardiac Events MACE and in-segment late lumen loss at 9 months between the CoStar Paclitaxel-Eluting Coronary Stent System and the TAXUS Express2 Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease
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