Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371423
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2006-08-31
Brief Title:
Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Multi-center Single-arm Study of the TAXUS Liberté-SR Stent for the Direct Stenting Treatment of Patients With de Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2012-02
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:
TAXUS ATLAS Direct Stent is a global multi-center single-arm noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted direct stenting versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty pre-dilatation The Control group consists of patients in the main TAXUS ATLAS trial in which pre-dilatation was mandatory The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation The primary hypothesis is that late outcomes with direct stenting of the TAXUS Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TAXUS ATLAS Direct Stent | None | None | None |