Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235144
Status:
COMPLETED
Last Update Posted:
2009-05-11
First Post:
2005-10-04
Brief Title:
The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
E-Sirius Study a European Multi-Center Randomized Double-Blind Study of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2009-05
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:
E-SIRIUS
Brief Summary:
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent Both stents are mounted on the Raptor Rapid Exchange Stent Delivery System
Detailed Description:
This is a multicenter up to 35 centers prospective randomized double blind study This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent both mounted on the Raptor Rapid Exchange Stent Delivery System A total of 350 patients will be entered in the study and will be randomized on a 11 basis Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent Patients will be followed at 30 days 6 9 and 12 months and at 2 3 4 5 6 7 and 8 years post-procedure with all patients undergoing repeat angiography at 8 months Medical resource use during the 5 years follow-up period will be collected and analyzed
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