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ANCHOR (Aneurysm Treatment Using the HeliFX Aortic Securement System Global Registry)


Aneurysm Treatment Using the HeliFX Aortic Securement System Global Registry




Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus HeliFX Aortic Securement 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 HeliFX Aortic Securement System is warranted. 2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the investigator believes that use of the EndoAnchor device 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 IFC 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 recommendations.

Study Status: Recruiting


Condition Intervention Phase
Abdominal Aortic Aneurysm Device: HeliFX Aortic Securement System
Procedure: AAA endograft placement
Device: Use of Aptus HeliFX Aortic Securement System (EndoAnchors)

Verified by Aptus Endosystems August, 2012

Sponsored by: Aptus Endosystems
Information provided by: Aptus Endosystems identifier: NCT01534819

Study Type: Interventional

Study Design: Observational Model: Cohort, Time Perspective: Prospective

Cleveland Clinic
Cleveland, Ohio 44195
United States

Jean-Paul de Vries, MD., Principal Investigator
William Jordan, MD., Principal Investigator

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