Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478673
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2007-05-24
Brief Title:
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System SONOMA
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
The NexStent Carotid Stent System A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ Embolic Protection System
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONOMA
Brief Summary:
The primary objective of the SONOMA Registry is to confirm the safety of the NexStent Carotid Stent System and FilterWire EZ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that might occur
Detailed Description:
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers
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 |
|---|---|---|---|
| SONOMA | None | None | None |