Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01534819
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2012-02-09
Brief Title:
ANCHOR Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry
Sponsor:
Medtronic Cardiovascular
Organization:
Medtronic Cardiovascular
Study Overview
Official Title:
Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
ANCHOR
Brief Summary:
The ANCHOR registry is a multi-center post-market non-interventional non-randomized prospective study
Subjects must sign an ICF prior to obtaining any study specific information Subjects are eligible to be consented up to 30 days post-procedure
Enrolled subjects will be followed as per local standard of care for up to 5 years post procedure Study recommended follow-up is per SVS and ESVS guidance
Subjects must sign an ICF prior to obtaining any study specific information Subjects are eligible to be consented up to 30 days post-procedure
Enrolled subjects will be followed as per local standard of care for up to 5 years post procedure Study recommended follow-up is per SVS and ESVS guidance
Detailed Description:
The objective of the ANCHOR registry is to expand the clinical knowledge based on the use of the Heli-FX EndoAnchor System This registry will include real world use over a broad spectrum of geographies by a wide variety of practicing clinicians and with a minimal degree of subject selection criteria
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