Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103591
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-10-19
Brief Title:
Controlled Arterial Protection to Ultimately Remove Embolic Material
Sponsor:
EmStop Inc
Organization:
EmStop Inc
Study Overview
Official Title:
Controlled Arterial Protection to Ultimately Remove Embolic Material
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
CAPTURE-1
Brief Summary:
The objective of this study is to demonstrate device feasibility safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the US
Detailed Description:
The investigation is a prospective multi-center single arm feasibility study Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure This is a treatment-only feasibility investigation intended to capture and characterize outcomes especially safety outcomes with the EmStop System
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None