Last updated on January 2019

ANCHOR (Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry)


Brief description of study

Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus Heli-FX EndoAnchor System in conjunction with commercially available non-Aptus Endografts will be divided, as appropriate, into two groups.

  1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA where the investigator believes the proximal aortic neck is challenging such that the risk of failure or fixation and/or sealing is great enough so that the use of the Heli-FX EndoAnchor System is warranted.
  2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the investigator believes that use of the Heli-FX EndoAnchor System is warranted to A- Treat existing graft migration and/or type 1a endoleak, with or without the concurrent use of other devices. B- Treat subjects believed to be at risk for migration and/or Type 1a endoleak

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 Study Description

Study Arms:

Abdominal Arm: Subjects with abdominal aortic aneurysms that do not require placement of EndoAnchors above the level of the renal arteries will be considered part of the abdominal arm. If a renal artery or any visceral artery requires (a) chimney procedure(s), the subject will be considered part of the Advanced Disease arm.

Thoracic Arm: Subjects with thoracic aortic aneurysms that do not require placement of any EndoAnchors proximal to the left common carotid artery (LCCA) or distal to the celiac artery. Thoracic procedures which require arch vessel transposition(s) or bypass procedures to the LCCA or brachiocephalic artery, chimney procedures into any arch or visceral artery(s), or hybrid open-endovascular repairs to the aorta will be considered part of the Advanced Disease Arm.

Advanced Disease Arm: To collect data on consecutively treated patients, the Advanced Disease Arm will be comprised of subjects that required placement of EndoAnchors proximal to the LCCA or in the visceral segment of the aorta distal to the celiac artery and proximal to the renal arteries. Subjects with thoracic procedures which require arch vessel transposition(s) or bypass (except to the left subclavian artery) or hybrid open-endovascular procedures as well as those with abdominal or thoracic procedures that require chimney procedures into any renal or visceral artery should also be included in the Advanced Disease arm.

Primary Group: Assess the Aptus HeliFX Aortic Securement System placed at the time of initial endograft implantation, either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.

Revision Group: Assess the Aptus HeliFX Aortic Securement System in subjects with previously implanted commercial endografts, for the prevention of graft migration and the treatment of Type Ia endoleak.

Clinical Study Identifier: NCT01534819

Contact Investigators or Research Sites near you

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Edith Willigendael, MD

Medisch Spectrum Twente
Enschede, Netherlands
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Recruitment Status: Open


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