NCT01534819: ANCHOR

Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

Completed Last updated 13 April 2026

What this trial tests

trial testing EndoAnchor™ in Aortic Aneurysm in 1,090 participants. Completed in 8 April 2026.

Timeline

1 April 2012

Primary endpoint
12 November 2020

8 April 2026

Quick facts

Lead sponsor	Medtronic Cardiovascular
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,090
Start date	1 April 2012
Primary completion	12 November 2020
Estimated completion	8 April 2026
Sites	87 locations across United States, Australia, Austria, France, Germany, Italy, Netherlands, New Zealand

Drugs / interventions tested

• EndoAnchor™
• endovascular treament

Conditions studied

• Aortic Aneurysm — all drugs for Aortic Aneurysm →

Sponsor

Medtronic Cardiovascular — full company profile →

Who can join

18 and older, any sex, with Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
  Time frame: Through 12 months
  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 treat
• Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
  Time frame: Through 12 months
  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
• Protocol C has composite primary safety endpoint
  Time frame: Through 12 months
  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
• Protocol C have composite primary effectiveness endpoint
  Time frame: Through 12 months
  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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy.
   Jordan WD, de Vries JP, Ouriel K, Mehta M, et al · · 2015 · cited 36× · PMID 25809354 · DOI 10.1177/1526602815574685
2. Techniques and future perspectives for the prevention and treatment of endoleaks after endovascular repair of abdominal aortic aneurysms.
   Orgera G, Tipaldi MA, Laurino F, Lucatelli P, et al · · 2019 · cited 9× · PMID 31549250 · DOI 10.1186/s13244-019-0774-y
3. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair.
   van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, et al · · 2019 · cited 5× · PMID 30907259 · DOI 10.1177/1526602819837753