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Which stent graft shrinks aneurysms best? new trial aims to find out.

NCT ID NCT05378347

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study compares two medical devices (Endurant and Excluder stent grafts) used to treat abdominal aortic aneurysms—a bulging blood vessel in the belly that can be life-threatening if it bursts. About 600 people with large aneurysms will be randomly assigned to get one of the two devices. The main goal is to see which device leads to more shrinkage of the aneurysm one year after the procedure.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

May 2031

An estimate. End dates often move.

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.

Ages

20 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.

Inclusion Criteria: * Subject and the treating physician agree that the subject will return for all required follow up visits * Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board * Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda. * Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region. Exclusion Criteria: * Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial * Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator * Subject has an aneurysm that is: 1. Suprarenal/pararenal/juxtarenal 2. Isolated ilio-femoral 3. Mycotic 4. Inflammatory 5. Pseudoaneurysm 6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries 7. Ruptured 8. Symptomatic AAA * Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck. * Subject requires emergent aneurysm treatment, for example, trauma or rupture * Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome * Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease * Planned use of aorto-uni-iliac (AUI) main body device * Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc. * Planned coverage of the internal iliac artery/arteries * Subject has an estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2 or subject is on dialysis * Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion * Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion * Subject is of childbearing potential in whom pregnancy cannot be excluded * Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment * Subject belongs to a vulnerable population per investigator's judgment * Subject has an active COVID-19 infection or relevant history of COVID- 19

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

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

Abdominal aortic aneurysm Abdominal aortic aneurysm >= 5.0 centimeters in female (disorder) Abdominal aortic aneurysm >= 5.5 centimeters in male (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    63 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Citta della Salute e della Scienza di Torino

    RECRUITING

    Torino, 10126, Italy

  • Albany Medical College

    WITHDRAWN

    Albany, New York, 12208, United States

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, Netherlands

  • Asahikawa Medical University Hospital

    RECRUITING

    Asahikawa, Hokkaido, 078-8510, Japan

  • Ascension Via Christi Saint Francis

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Assistance Publique - Hopitaux de Marseille Hopital de la Timone

    RECRUITING

    Marseille, Marseille Cedex, 13385, France

  • Azienda Ospedaliera Universitaria Federico II

    RECRUITING

    Naples, 80131, Italy

  • Baystate Medical Center

    RECRUITING

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63003, France

  • Cardiovascular Surgery Clinic

    WITHDRAWN

    Memphis, Tennessee, 38120, United States

  • Catharina Ziekenhuis

    RECRUITING

    Eindhoven, 5623 EJ, Netherlands

  • Centre Hospitalier Universitaire Vaudois

    RECRUITING

    Lausanne, 1011, Switzerland

  • Chi Mei Medical Center

    RECRUITING

    Tainan, 710402, Taiwan

  • China Medical University Hospital

    RECRUITING

    Taichung, 404327, Taiwan

  • Denver Health Medical Center

    RECRUITING

    Denver, Colorado, 80204, United States

  • Elisabeth Hospital Essen

    RECRUITING

    Essen, 45138, Germany

  • Erasmus Medisch Centrum

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Hamamatsu University Hospital

    RECRUITING

    Hamamatsu, Shizuoka, 431-3125, Japan

  • Helsinki University Hospital

    RECRUITING

    Helsinki, 00290, Finland

  • Hoag Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hopital de Hautepierre - CHU de Strasbourg

    RECRUITING

    Strasbourg, 67200, France

  • Hospices Civils de Lyon-CHU Lyon

    WITHDRAWN

    Lyon, 69002, France

  • Hospital Universitario Son Espases

    RECRUITING

    Palma, Mallorca, 07210, Spain

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Keio University Hospital

    RECRUITING

    Shinjuku-Ku, Tokyo, 160-0016, Japan

  • Kuopio University Hospital

    RECRUITING

    Kuopio, 70200, Finland

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, 6000, Switzerland

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medstar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Niigata University Medical and Dental Hospital

    RECRUITING

    Chuo Ku, Niigata, 951-8510, Japan

  • Northshore University Health System

    RECRUITING

    Skokie, Illinois, 60076, United States

  • Northside Hospital Forsyth

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Northwell Health Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Novant Health Forsyth Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Osaka Keisatsu Hospital

    RECRUITING

    Osaka, 543-8922, Japan

  • Oxford University Hospitals NHS Trust - John Radcliffe Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Prisma Health

    WITHDRAWN

    Greenville, South Carolina, 29615, United States

  • Rijnstate Hospital

    RECRUITING

    Arnhem, The Netherlands, 6815 AD, Netherlands

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • St. Franziskus Hospital Munster

    RECRUITING

    Münster, 48145, Germany

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Universitatsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • University Hospital Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • University Hospital Cologne

    RECRUITING

    Cologne, 50937, Germany

  • University Hospital Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • University Hospital of Larisa

    RECRUITING

    Larissa, 41110, Greece

  • University Hospital rechts der Isar of the Technical University Munich

    RECRUITING

    Munich, 81675, Germany

  • University Hospitals, Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California Davis Medical Center

    WITHDRAWN

    Sacramento, California, 95817, United States

  • University of California Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • University of California San Francisco UCSF Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • VA Maryland Health Care System

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

  • Yale Center for Clinical Investigation

    RECRUITING

    New Haven, Connecticut, 06519, United States

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Other studies related to the condition(s) this trial covers.