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

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University of Alabama

Birmingham, AL United States
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Arizona Heart Institute

Phoenix, AZ United States
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Loma Linda VA Medical Center

Loma Linda, CA United States
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El Camino Hospital

Mountain View, CA United States
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Harbor - UCLA

Torrance, CA United States
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Florida Hospital

Orlando, FL United States
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University of Chicago

Chicago, IL United States
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HeartCare Midwest

Peoria, IL United States
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Evanston Hospital

Skokie, IL United States
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Southern Illinois University

Springfield, IL United States
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Michigan Vascular Center

Flint, MI United States
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William Beaumont Hospital

Royal Oak, MI United States
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Albany Medical Center

Albany, NY United States
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New York University

New York, NY United States
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Chapel Hill, NC United States
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Cleveland Clinic

Cleveland, OH United States
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Pinnacle Health

Wormleysburg, PA United States
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Lexington Medical Center

West Columbia, SC United States
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CHI Memorial Hospital Chattanooga

Chattanooga, TN United States
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Norfolk Sentara Hospital

Norfolk, VA United States
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Rijnstate Hospital

Arnhem, Netherlands
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St. Antonius Hospital

Nieuwegein, Netherlands
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UMC Utrecht

Utrecht, Netherlands
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Emory University Hospital

Atlanta, GA United States
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Vascular Health Partners

Queensbury, NY United States
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Pius Hospital

Oldenburg, Germany
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Hospital Universitario Donostia

Donostia / San Sebastián, Spain
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Wythenshawe Hospital

Manchester, United Kingdom
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Recruitment Status: Open

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