ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
NCT ID: NCT01534819
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1090 participants
OBSERVATIONAL
2012-04-30
2026-04-24
Brief Summary
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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 Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Protocol B, abdominal arm, revision group
AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Protocol B, abdominal arm, primary group
AAA subjects 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.
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Protocol B, thoracic arm, revision group
TAA subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Protocol B, thoracic arm, primary group
TAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Protocol B, advanced disease arm, revision group
Advanced disease subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Protocol B, advanced disease arm, primary group
Advanced disease subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation.
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Protocol C, abdominal arm, short neck, primary group
Planned use of Heli-FX™ in conjunction with the Endurant II/IIs endograft in AAA subjects with short proximal necks (≥ 4 mm and \< 10 mm) in primary group.
EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Interventions
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EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
endovascular treament
implantation of a device inserted through an artery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject ≥ 18 years old
3. Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
4. Subject is willing and able to comply with standard of care followup evaluations
5. Subject has a previously implanted endograft or will be undergoing repair, with one of the following aortic aneurysm endograft devices:
* Cook Zenith or Cook Zenith TX2
* Gore Excluder or TAG
* Medtronic AneuRx
* Medtronic Talent
* Medtronic Endurant or Valiant
* Any additional third party AAA endograft device that is commercially available and listed as compatible with Heli-FX™ in the IFU
6. Subject's iliac/femoral access is compatible with:
* a 16 French sheath (abdominal subjects)
* 18 French sheath (thoracic subjects)
* Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)
7. Subject has a previously implanted endograft that has migrated or has a Type I endoleak within the aorta or will undergo implantation of an endograft that in the opinion of the investigator will be at increased risk of such complications
* Subjects with asymptomatic or symptomatic abdominal aortic aneurysms that will receive the Heli-FX™ in conjunction with the Endurant II/IIs endograft as part of their planned EVAR treatment
* Subject ≥ 18 years old
* Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
* Subject is willing and able to comply with standard of care followup evaluations
* Subject will be undergoing AAA repair with the bifurcated main body Endurant II/IIs stent graft in conjunction with Heli-FX™ with a proximal neck length of ≥ 4mm to \< 10mm and treated in accordance with the Endurant II/IIs and Heli-FX™ IFUs
* Subject's iliac/femoral access is compatible with a 16 French sheath
Exclusion Criteria
2. Subject has a life expectancy of less than 1 year
3. Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
4. Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry
5. Subject has an active or known history of bleeding diathesis
6. Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
7. Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall
8. Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall
9. Subject has an aortic dissection that involves an area to be treated with EndoAnchor™
10. Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
11. Subject is pregnant
Protocol C:
* Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
* Subject has a life expectancy of less than 1 year
* Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
* Subject was previously treated with EndoAnchor™ implants in the same segment of the aorta that will be treated within the registry, or has a previously implanted AAA endograft that has migrated or has a Type Ia endoleak, or is being treated for a ruptured abdominal aortic aneurysm, or has planned usage of an Endurant II/IIs AUI main body stent graft configuration
* Subject has an active or known history of bleeding diathesis
* Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
* Significant thrombus or calcium at the location of planned EndoAnchor™ device implantation that precludes adequate EndoAnchor™ implant penetration of the aortic wall
* Use where, for whatever reason, each EndoAnchor™ implant is not anticipated to adequately penetrate into the aortic wall
* Subject has an aortic dissection that involves an area to be treated with EndoAnchor™ implants
* Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
* Subject is pregnant
* Physician does not intend to treat subject on-label per the Endurant II/IIs and Heli-FX™ IFU requirements or if the physician intends to use Heli-FX™ in a chimney procedure.
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Paul de Vries, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Medisch Centrum Groningen, Netherlands
William Jordan, MD
Role: PRINCIPAL_INVESTIGATOR
Augusta University Health, United States
Locations
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University of Alabama
Birmingham, Alabama, United States
Abrazo Arizona Heart Institute
Phoenix, Arizona, United States
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
VA Loma Linda Medical Center
Loma Linda, California, United States
El Camino Hospital
Mountain View, California, United States
University of California Irvine Medical Center
Torrance, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
MedStar Georgetown University Hospital Vascular Surgery Dept.
Washington D.C., District of Columbia, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Kaiser Permanente Moanalua Medical Center and Clinic
Honolulu, Hawaii, United States
HeartCare Midwest
Peoria, Illinois, United States
Evanston Hospital
Skokie, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess-Harvard
Boston, Massachusetts, United States
Michigan Vascular Center
Flint, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Washington University School of Medicine, Barnes Jewish West County Hospital
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
New York University Langone Medical Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Maimonides Medical Center
New York, New York, United States
Vascular Health Partners
Queensbury, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Mission Hospital
Asheville, North Carolina, United States
University of North Carolina (UNC) Memorial Hospital
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Pinnacle Harrisburg Campus
Wormleysburg, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
CHI Memorial Hospital Chattanooga
Chattanooga, Tennessee, United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
Scott and White Medical Center
Temple, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Harborview Medical Center, University of Washington
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, , Australia
Dandenong Hospital
Dandenong, , Australia
Royal Perth Hospital
Perth, , Australia
Sir Charles Gairdner Hospital
Perth, , Australia
Royal North Shore Hospital
St Leonards, , Australia
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, , Austria
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, , Austria
Hôpital Pontchaillou
Rennes, , France
Nouvel Hôpital Civil
Strasbourg, , France
Medizinische Fakultät der RWTH
Aachen, , Germany
Deutsches Herzzentrum
Berlin, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Park Hospital Leipzig
Leipzig, , Germany
St. Bonifatius Hospital
Lingen, , Germany
Klinikum Ludwigsburg
Ludwigsburg, , Germany
LMU Kilinikum der Universitaet Muenchen
Munich, , Germany
Technical University of Munich
Munich, , Germany
St. Franzsikus-Hospital GmbH
Münster, , Germany
Klinikum Nuremberg
Nuremberg, , Germany
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
AO Universitaria Policlinico
Roma, , Italy
Unihospital San Giovanni di Dio Ruggi d'Aragona
Salerno, , Italy
University of Siena
Siena, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, , Italy
Rijnstate Hospital
Arnhem, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Maasstad Hospital Rotterdam
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Narodny ustav srdcovych a cievnych chorob
Nové Mesto, , Slovakia
Thorax Institute Hospital Clinic
Barcelona, , Spain
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Malmo University Hospital
Malmo, , Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
Liverpool, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Ouriel K, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Workgroup Members. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg. 2014 Oct;60(4):885-92.e2. doi: 10.1016/j.jvs.2014.04.063. Epub 2014 Jul 31.
Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, Moore WM Jr, de Vries JP. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular. 2016 Apr;24(2):177-86. doi: 10.1177/1708538115590727. Epub 2015 Jun 10.
Arko FR 3rd, Pearce BJ, Henretta JP, Fugate MW, Torsello G, Panneton JM, Peng Y, Edward Garrett H Jr. Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry. J Vasc Surg. 2023 Dec;78(6):1418-1425.e1. doi: 10.1016/j.jvs.2023.07.058. Epub 2023 Aug 7.
van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, de Vries JPM. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair. J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.
Arko FR 3rd, Stanley GA, Pearce BJ, Henretta JP, Fugate MW, Mehta M, Torsello G, Panneton JM, Garrett HE Jr. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.
Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.
Jordan WD Jr, de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Henretta J. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. J Endovasc Ther. 2015 Apr;22(2):163-70. doi: 10.1177/1526602815574685.
Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg. 2015 Jun;61(6):1383-90.e1. doi: 10.1016/j.jvs.2014.12.063. Epub 2015 Feb 28.
de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Jordan WD Jr; Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry ANCHOR Trial. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014 Dec;60(6):1460-7.e1. doi: 10.1016/j.jvs.2014.08.089. Epub 2014 Oct 3.
Related Links
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Medtronic
Other Identifiers
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Anchor Post Market Registry
Identifier Type: -
Identifier Source: org_study_id