Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283413
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2006-01-27
Brief Title:
Symbiot III A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Symbiot III A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
Status:
COMPLETED
Status Verified Date:
2009-10
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 objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein bypass graft disease
Detailed Description:
Symbiot III was a prospective multi-center randomized controlled trial to evaluate the safety and efficacy of the Symbiot stent compared to bare metal stents in the treatment of symptomatic ischemic saphenous vein graft disease Randomization was stratified by the intended use of intravenous glycoprotein IIbIIIa inhibitors and by the intended use of approved distal protection to ensure approximate balance between study treatments within each of the strata The primary outcome variable for the study was target lesion percent diameter stenosis at 8 months post-implant
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 |
|---|---|---|---|
| S2001 | None | None | None |