Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233792
Status:
COMPLETED
Last Update Posted:
2007-10-12
First Post:
2005-10-04
Brief Title:
FIM-BR - First-in-Man Study Brazil Part With Sirolimus-Coated BX VELOCITY Stent
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
An Evaluation of the Sirolimus Coated Modified BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo or Restenotic Native Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2007-10
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:
This is a single center non-randomized study Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure
Detailed Description:
This is a single center non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus 140µgcm2 and formulated for fast or slow release The sirolimus coated stent is mounted on the Raptor OTW SDS Approximately 30 patients with de novo or restenotic native coronary artery lesions 18mm in length and 30 to 35 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stents Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months 12 months 24 months and 48 months
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