Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT03816202
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2019-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Sponsor:
Integra LifeSciences Corporation
Organization:
Study Overview
Official Title:
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Status:
COMPLETED
Status Verified Date:
2022-01
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 primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: