ANCHOR: Aneurysm Treatment using the HeliFX Aortic Securement System Global Registry | Dartmouth-Hitchcock
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ANCHOR: Aneurysm Treatment using the HeliFX Aortic Securement System Global Registry
Principal Investigator (?)
Study Number
F12079
Summary
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. 
Phase (?)
Phase III
Sponsor (?)
Contact

Wendy Aarnio

Available at the following location(s)

Lebanon

View more details from ClinicalTrials.gov.

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