Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489541
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2007-06-20
Brief Title:
TAXUS PERSEUS Small Vessel
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Prospective Evaluation in a Non-Randomized Trial of the Safety and Efficacy of the Use of the TAXUS ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels
Status:
COMPLETED
Status Verified Date:
2014-04
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:
PERSEUS SV
Brief Summary:
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system TAXUS ElementTM for the treatment of de novo atherosclerotic lesions of up to 20 mm in length in native coronary arteries of 225 mm to 275 mm diameter
Detailed Description:
This is a prospective multi-center single-arm superiority trial to assess the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of 20 mm in length in native coronary arteries with visual RVD of 225 mm to 275 mm diameter
Two hundred twenty-four 224 subjects will be treated with the TAXUS Element stent at a maximum of 35 clinical sites Follow-up at 30 days 9 months including angiography and 1 year will be completed in all subjects enrolled in the study Eligible subjects will have annual follow-up until 5 years post-index procedure
Two hundred twenty-four 224 subjects will be treated with the TAXUS Element stent at a maximum of 35 clinical sites Follow-up at 30 days 9 months including angiography and 1 year will be completed in all subjects enrolled in the study Eligible subjects will have annual follow-up until 5 years post-index procedure
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 |
|---|---|---|---|
| S2043-PIVOT-2006 | None | None | None |