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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,090

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach

12 countries

82 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14 years study duration

First Submitted

Initial submission to the registry

February 9, 2012

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed

1 month until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed

8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2020

Completed

5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

8.6 years

First QC Date

February 9, 2012

Last Update Submit

April 13, 2026

Conditions

Aortic Aneurysm

Keywords

EndograftEndurantHeli-FX™EndoAnchor™Short neckEndovascular treatmentInterventional treatment of aortic aneurysmAbdominal aortic aneurysmAAAThoracic aortic aneurysmTAAAdvanced disease

Outcome Measures

Primary Outcomes (4)

Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
The primary safety endpoint is defined by: i. freedom from device-related serious adverse events at 12 months and ii. freedom from procedure-related serious adverse events at 12 months iii. freedom from aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Through 12 months
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
The primary effectiveness endpoint requires all of the following: i successful implantation of the minimum number of EndoAnchor™ and ii freedom from migration at 12 months and iii freedom from Type I endoleak at the targeted attachment site(s) at 12 months
Through 12 months
Protocol C has composite primary safety endpoint
The primary safety endpoint is defined by: 1. device-related serious adverse events at 12 months 2. aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Through 12 months
Protocol C have composite primary effectiveness endpoint
The primary effectiveness endpoint is treatment success which is defined as the successful implantation of EndoAnchor™ implants at the index procedure, and the absence of: 1. migration at 12 months and 2. Type I endoleak at the targeted attachment site(s) at 12 months
Through 12 months

Secondary Outcomes (2)

Protocol B has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.
Through 5 years
Protocol C has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.
Through 5 years

Study Arms (7)

Protocol B, abdominal arm, revision group

AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak