Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371748
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2006-09-01
Brief Title:
A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
TAXUS ATLAS SMALL VESSEL A Multi-center Single-arm Study of the TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels
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 Small Vessel is a global multi-center single-arm trial of patients with coronary arteries less than 25 mm in diameter who are treated with the TAXUS Liberté stent versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V patients treated with a 225 mm stent The objective of the study is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 225 mm stent in de novo lesions The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels
Detailed Description:
TAXUS ATLAS Small Vessel is a global multi-center single-arm trial of patients receiving the TAXUS Liberté-SR 225 mm paclitaxel-eluting stent The results will be compared with two different historical control groups The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 225 mm TAXUS Express-SR paclitaxel-eluting stent The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 225 mm stent in de novo lesions versus the TAXUS Express-SR stent The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 25 mm or a 225 mm bare metal Express stent The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 225 mm stent in de novo lesions versus the Express bare metal stent The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels
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 Small Vessel | None | None | None |