Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-13 @ 3:08 AM
Study NCT ID:
NCT04618718
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2020-10-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The PROTEMBO C Trial
Sponsor:
Protembis GmbH
Organization:
Study Overview
Official Title:
Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C Trial
Status:
COMPLETED
Status Verified Date:
2025-04
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:
None
Brief Summary:
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: