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
Abdominal Aortic Aneurysm
Device: HeliFX Aortic Securement System
Procedure: AAA endograft placement
Device: Use of Aptus HeliFX Aortic Securement System (EndoAnchors)
Information provided by:
Study Type: Interventional
Study Design: Observational Model: Cohort, Time Perspective: Prospective
Cleveland, Ohio 44195
Jean-Paul de Vries, MD., Principal Investigator
William Jordan, MD., Principal Investigator