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

Study:

Aneurysm Treatment Using the HeliFX Aortic Securement System Global Registry

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

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

Verified by Aptus Endosystems August, 2012

Sponsored by: Aptus Endosystems
Information provided by: Aptus Endosystems
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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