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New anchor device aims to secure aortic aneurysm repairs

NCT ID NCT01534819

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This registry tracked over 1,000 patients who received the Heli-FX EndoAnchor device during endovascular repair of aortic aneurysms. The device is designed to help hold the endograft in place and prevent leaks. Patients were followed for up to 5 years to see how safe and effective the device is in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heli-FX EndoAnchor device (a small anchor implanted through an artery to secure an endograft)
What this could lead to
If successful, this device could help prevent endograft migration and leaks, improving long-term outcomes for aortic aneurysm patients.
What could go wrong
This is an observational registry, not a randomized trial, so results may not prove the device is better than standard care. Risks include device-related complications or aneurysm rupture.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,090 people

The number who actually took part.

Started

Apr 2012

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Protocol B: subjects with AAA, TAA, or advanced aortic aneurysmal disease treated with the Heli-FX™ EndoAnchor™ System in conjunction with commercially available abdominal and thoracic Endografts, in both "Primary" and "Revision" settings and who meet the inclusion/exclusion criteria. Protocol C:The intended population will include those subjects with short (≥ 4 mm and \< 10 mm) infrarenal proximal neck lengths who are appropriate candidates for infrarenal AAA treatment with the Heli-FX™ EndoAnchor™ System in conjunction with the Endurant II/IIs endograft system and who meet the inclusion/exclusion criteria

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Protocol B: Inclusion criteria: 1. Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms 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 Exclusion criteria: 1. Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt) 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: Inclusion criteria: * 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: * 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.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm aortic aneurysm thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic aneurysm

Contacts and locations

Locations

  • A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

    Innsbruck, Austria

  • AO Universitaria Policlinico

    Roma, Italy

  • Abrazo Arizona Heart Institute

    Phoenix, Arizona, 84006, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Allgemeines Krankenhaus - Universitätskliniken Wien

    Vienna, Austria

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy

  • Baptist Cardiac & Vascular Institute

    Miami, Florida, 33176, United States

  • Baptist Memorial Hospital-Memphis

    Memphis, Tennessee, 38120, United States

  • Beth Israel Deaconess-Harvard

    Boston, Massachusetts, 02215, United States

  • CHI Memorial Hospital Chattanooga

    Chattanooga, Tennessee, 37403, United States

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Switzerland

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Concord Repatriation General Hospital

    Concord, NSW 2139, Australia

  • Dandenong Hospital

    Dandenong, VIC 3175, Australia

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Deutsches Herzzentrum

    Berlin, Germany

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • El Camino Hospital

    Mountain View, California, 94040, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322-1059, United States

  • Evanston Hospital

    Skokie, Illinois, 60077, United States

  • Florida Hospital

    Orlando, Florida, 32751, United States

  • Harbor - UCLA Medical Center

    Torrance, California, 90509, United States

  • Harborview Medical Center, University of Washington

    Seattle, Washington, 98104, United States

  • HeartCare Midwest

    Peoria, Illinois, 61614, United States

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Spain

  • Hôpital Pontchaillou

    Rennes, France

  • Imperial College Healthcare NHS Trust

    London, United Kingdom

  • John L McClellan Memorial Veterans Hospital

    Little Rock, Arkansas, 72205, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21401, United States

  • Kaiser Permanente Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819, United States

  • Klinikum Ludwigsburg

    Ludwigsburg, Germany

  • Klinikum Nuremberg

    Nuremberg, Germany

  • LMU Kilinikum der Universitaet Muenchen

    Munich, Germany

  • Lexington Medical Center

    West Columbia, South Carolina, 29169, United States

  • Maasstad Hospital Rotterdam

    Rotterdam, Netherlands

  • Maimonides Medical Center

    New York, New York, 11219, United States

  • Malmo University Hospital

    Malmö, Sweden

  • MedStar Georgetown University Hospital Vascular Surgery Dept.

    Washington D.C., District of Columbia, 20007, United States

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Medizinische Fakultät der RWTH

    Aachen, Germany

  • Michigan Vascular Center

    Flint, Michigan, 98507, United States

  • Mission Hospital

    Asheville, North Carolina, 28806, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Narodny ustav srdcovych a cievnych chorob

    Nové Mesto, Slovakia

  • New York University Langone Medical Center

    New York, New York, 10016, United States

  • Nouvel Hôpital Civil

    Strasbourg, France

  • Park Hospital Leipzig

    Leipzig, Germany

  • Rijnstate Hospital

    Arnhem, Netherlands

  • Royal North Shore Hospital

    St Leonards, NSW 2065, Australia

  • Royal Perth Hospital

    Perth, WA 6000, Australia

  • Scott and White Medical Center

    Temple, Texas, 76508, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Sir Charles Gairdner Hospital

    Perth, Australia

  • Southern Illinois University

    Springfield, Illinois, 62702, United States

  • St. Antonius Hospital

    Nieuwegein, Netherlands

  • St. Bonifatius Hospital

    Lingen, Germany

  • St. Franzsikus-Hospital GmbH

    Münster, Germany

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Technical University of Munich

    Munich, Germany

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

    Newcastle upon Tyne, United Kingdom

  • The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

    Liverpool, United Kingdom

  • Thorax Institute Hospital Clinic

    Barcelona, Spain

  • UMC Utrecht

    Utrecht, Netherlands

  • UPMC Pinnacle Harrisburg Campus

    Wormleysburg, Pennsylvania, 17043, United States

  • Unihospital San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84131, Italy

  • University Hospital Heidelberg

    Heidelberg, Germany

  • University of Alabama

    Birmingham, Alabama, 35294, United States

  • University of California Irvine Medical Center

    Torrance, California, 90502-2004, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of North Carolina (UNC) Memorial Hospital

    Chapel Hill, North Carolina, 27599, United States

  • University of Siena

    Siena, Italy

  • University of South Florida

    Tampa, Florida, 33606, United States

  • UniversitätsSpital Zürich

    Zurich, Switzerland

  • VA Loma Linda Medical Center

    Loma Linda, California, 92357, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vascular Health Partners

    Queensbury, New York, 12804, United States

  • Washington University School of Medicine, Barnes Jewish West County Hospital

    St Louis, Missouri, 63110, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, 48703, United States

  • Wythenshawe Hospital

    Manchester, United Kingdom

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

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