Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292474
Status:
COMPLETED
Last Update Posted:
2008-10-08
First Post:
2006-02-14
Brief Title:
TAXUS IV-SR Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
TAXUS IV-SR Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent
Status:
COMPLETED
Status Verified Date:
2008-10
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 ultimate goal of a paclitaxel eluting stent system TAXUS stent is to prevent restenosis by blunting the initial response to stent implant injury and sustaining the arrested response until vascular healing has taken place
The purpose of the TAXUS IV-SR trial is to study the safety and efficacy of the TAXUS Stent under controlled trial circumstances used in the treatment of new coronary artery lesions heart blockages This clinical investigation will evaluate the safety and effectiveness of the TAXUS Stent with 1 ugmm2 loaded drugstent surface area of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier system for treatment of new coronary artery lesions
The purpose of the TAXUS IV-SR trial is to study the safety and efficacy of the TAXUS Stent under controlled trial circumstances used in the treatment of new coronary artery lesions heart blockages This clinical investigation will evaluate the safety and effectiveness of the TAXUS Stent with 1 ugmm2 loaded drugstent surface area of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier system for treatment of new coronary artery lesions
Detailed Description:
This was a prospective randomized double-blind multicenter safety and efficacy trial Patients were stratified by presence or absence of medically treated diabetes mellitus and vessel diameter 30 mm or 30 mm then randomized 11 to receive either the TAXUS Stent or a Control stent Additional study stents were permitted to optimize outcomes The study was considered complete with regard to the primary endpoint after all patients enrolled had completed the 9 month follow-up
Enrollment of 1172 patients was planned 1326 were treated and randomized at 73 centers involving 76 sites by 8 July 2002 with 667 in the TAXUS group and 659 in the Control group
Enrollment of 1172 patients was planned 1326 were treated and randomized at 73 centers involving 76 sites by 8 July 2002 with 667 in the TAXUS group and 659 in the Control group
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 IV | None | None | None |