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

Contact Investigators or Research Sites near you

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Benjamin Pearce, MD

University of Alabama
Birmingham, AL United States
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Hannah Wessels

Arizona Heart Institute
Phoenix, AZ United States
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Mohammed Moursi, MD

John L McClellan Memorial Veterans Hospital
Little Rock, AR United States
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Christian Bianchi, MD

Loma Linda VA Medical Center
Loma Linda, CA United States
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James Joye, DO

El Camino Hospital
Mountain View, CA United States
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Carlos Donayre, MD

Harbor - UCLA
Torrance, CA United States
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Kristine Orion, MD

Yale University School of Medicine
New Haven, CT United States
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Barry Katzen, MD

Baptist Cardiac & Vascular Institute
Miami, FL United States
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David Varnagy, MD

Florida Hospital
Orlando, FL United States
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Murray Shames, MD

University of South Florida
Tampa, FL United States
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Peter Schneider, MD

Hawaii Permanente Medical Group
Honolulu, HI United States
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Hannah Wessels

University of Chicago
Chicago, IL United States
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Dale Mueller, MD

HeartCare Midwest
Peoria, IL United States
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NavYash Gupta, MD

Evanston Hospital
Skokie, IL United States
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Hannah Wessels

Southern Illinois University
Springfield, IL United States
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Robert Crawford, MD

Division of Cardiac Surgery UMD School of Medicine
Baltimore, MD United States
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Mahmoud Malas, MD

Johns Hopkins Bayview Medical Center
Baltimore, MD United States
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Marc Schermerhorn, MD

Beth Israel Deaconess-Harvard
Boston, MA United States
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Nitin Malhotra, MD

Michigan Vascular Center
Flint, MI United States
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Paul Bove, MD

William Beaumont Hospital
Royal Oak, MI United States
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Jeffery Jim, MD, MS

Washington University School of Medicine, Barnes Jewish West County Hospital
Saint Louis, MO United States
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Mark Fillinger, MD

Dartmouth-Hitchcock Medical Center
Lebanon, NH United States
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John Taggert, MD

Albany Medical Center
Albany, NY United States
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Mark Adelman, MD

New York University
New York, NY United States
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Paul Lajos, MD

Department of Surgery Mount Sinai Medical Center
New York, NY United States
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Apostolos Tassiopoulos, MD

Stony Brook University Medical Center
Stony Brook, NY United States
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John Henretta, MD

Carolina Vascular-Mission Hospital
Asheville, NC United States
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Mark Farber, MD

Chapel Hill, NC United States
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Frank Arko, MD

Carolinas Health Care Div. of Vascular and Endovascular Surgery
Charlotte, NC United States
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Mitchell Cox, MD

Duke University Medical Center
Durham, NC United States
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Matthew Eagleton, MD

Cleveland Clinic
Cleveland, OH United States
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David Loran, MD

Pinnacle Health
Wormleysburg, PA United States
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William M Moore, MD

Lexington Medical Center
West Columbia, SC United States
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Mark W Fugate, MD

CHI Memorial Hospital Chattanooga
Chattanooga, TN United States
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H. Edward Garrett, MD

Baptist Memorial Hospital-Memphis
Memphis, TN United States
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Thomas C Naslund, MD

Vanderbilt University Medical Center
Nashville, TN United States
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William Bohannon, MD

Scott and White Medical Center
Temple, TX United States
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Jean Panneton, MD

Norfolk Sentara Hospital
Norfolk, VA United States
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Benjaimn Starnes, MD

Harborview Medical Center, University of Washington
Seattle, WA United States
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Jean-Pierre Becquemin, MD

Henri Mondor Hospital
Creteil, France
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Burkhart Zipfel, MD

Deutsches Herzzentrum
Berlin, Germany
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Horst Sievert, MD

Cardiovascular Center Frankfurt
Frankfurt, Germany
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Dittmar Bockler, MD

University Hospital Heidelberg
Heidelberg, Germany
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Andrej Schmidt, MD

Park Hospital Leipzig
Leipzig, Germany
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Joerg Tessarek, MD

St. Bonifatius Hospital
Lingen, Germany
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Johannes Gahlen, MD

Klinikum Ludwigsburg
Ludwigsburg, Germany
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Ramin Banafsche, MD

LMU Kilinikum der Universitaet Muenchen
Munich, Germany
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Hans-Henning Eckstein, MD

Technical University of Munich
Munich, Germany
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Giovanni Torsello, MD

St. Franzsikus-Hospital GmbH
Munster, Germany
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Eric Verhoeven, MD

Klinikum Nuremberg
Nuremberg, Germany
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Carlo Setacci, MD

University of Siena
Siena, Italy
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Michael Reijnen, MD

Rijnstate Hospital
Arnhem, Netherlands
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Jean-Paul de Vries, MD

St. Antonius Hospital
Nieuwegein, Netherlands
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Bram Fioole, MD

Maasstad Hospital Rotterdam
Rotterdam, Netherlands
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F.L. Moll, MD

UMC Utrecht
Utrecht, Netherlands
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Vincent Riambau, MD

Thorax Institute Hospital Clinic
Barcelona, Spain
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Timothy Resch, MD

Malmo University Hospital
Malmo, Sweden
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Colin Bicknell, MD

Imperial College Healthcare NHS Trust
London, United Kingdom
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Edward Woo, MD

MedStar Georgetown University Hospital Vascular Surgery Dept.
Washington, WA United States
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William Jordan, MD

Emory University Hospital
Atlanta, GA United States
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Evan C Lipsitz, MD

Montefiore Medical Center
Bronx, NY United States
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Manish Mehta

Vascular Health Partners
Queensbury, NY United States
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Martin Freund, MD

A. . Landeskrankenhaus - Universit tskliniken Innsbruck
Innsbruck, Austria
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Christian Loewe, MD

Allgemeines Krankenhaus - Universit tskliniken Wien
Wien, Austria
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Alain Cardon, MD

H pital Pontchaillou
Rennes, France
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Fabien Thaveau, MD

Nouvel H pital Civil
Strasbourg, France
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Drosos Kotelis, MD

Medizinische Fakult t der RWTH
Aachen, Germany
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Chistoph-Maria Ratusinski, MD

Pius Hospital
Oldenburg, Germany
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Goetz Richter, MD

Katharinen hospital
Stuttgart, Germany
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Carlo Pratesi, MD

Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
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Pierfancesco Veroux, MD

AO Universitaria Policlinico
Roma, Italy
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Michelangelo Ferri, MD

Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Italy
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Edith Willigendael, MD

Medisch Spectrum Twente
Enschede, Netherlands
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Piotr Gutowski, MD

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM
Szczecin, Poland
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Ivan Vulev

Narodny ustav srdcovych a cievnych chorob
Nové Mesto, Slovakia
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Mariano de Blas, MD

Hospital Universitario Donostia
Donostia / San Sebastián, Spain
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Carlos Vaquero Puerta, MD

Hospital Cl nico Universitario de Valladolid
Valladolid, Spain
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Francois Saucy, MD

Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
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Mario Lachat, MD

Universit tsSpital Z rich
Zürich, Switzerland
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Marcus John Brooks, MD

North Bristol NHS Trust - Southmead Hospital
Bristol, United Kingdom
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Francesco Torella, MD

The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
Liverpool, United Kingdom
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Jonathan Ghosh, MD

Wythenshawe Hospital
Manchester, United Kingdom
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James McCaslin, MD

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, United Kingdom
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Recruitment Status: Open

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