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New study tests better ways to fix dangerous aortic bulges

NCT ID NCT04503395

Disease control Sponsor: FCRE (Foundation for Cardiovascular Research and Education) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares two advanced, less invasive surgical methods to treat abdominal aortic aneurysms (a bulging blood vessel) in people with a short neck area. About 204 adults will be randomly assigned to one of the two procedures. The goal is to see which approach is safer and more effective at preventing complications like leaks or the need for repeat procedures.

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 204 people

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

Started

May 2021

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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.

Inclusion Criteria: * Subject is \>18 years old * Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm * Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening * Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements. * Subject has provided written informed consent CT Angiographic Inclusion Criteria * Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use * Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm * Aortic neck diameter from 19 to 31mm * Infrarenal neck angulation ≤45° Exclusion Criteria: * Subject is participating in a concurrent study which may confound study results * Subject has a life expectancy \<2 year * Subject is female of childbearing potential in whom pregnancy cannot be excluded * Subject with eGFR \<30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis * Subject with a MI or CVA within 3 months prior to index procedure * Subject with known Connective Tissue Disease * Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment * Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm * Subject requires emergent aneurysm treatment, for example, trauma or rupture * Subject has a known hypersensitivity or allergies to study device implant material * Subject has an aneurysm that is: * Suprarenal, pararenal, or thoracoabdominal * Mycotic * Inflammatory * Pseudoaneurysm * Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \>50% * Pre-op stenosis of the renal arteries \> 50% * Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment 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.

Aortic aneurysm, abdominal

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 10 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 14212, United States

  • Amrois Paré Hospital (APHP)

    RECRUITING

    Boulogne, France

  • Az. Ospedaliera San Martino, Genova

    RECRUITING

    Genova, 16132, Italy

  • Az.Osped.Univers.S.Giovanni, Turin

    RECRUITING

    Turin, 10154, Italy

  • Azienda Ospedaliera Universitaria Integrata di Verona

    RECRUITING

    Verona, Italy

  • CRC thoracic Vascular Surgery, ZOL Genk

    RECRUITING

    Genk, 3600, Belgium

  • Catharina Ziekenhuis

    NOT_YET_RECRUITING

    Eindhoven, Netherlands

  • Centre Hospitalier Universitaire de Rennes

    RECRUITING

    Rennes, France

  • Corewell Health (Spectrum)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • HOSPITAL CLINICO UNIVERSITARIO Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Hospices Civils de lyon - Hôpital Edouard Herriot

    RECRUITING

    Lyon, France

  • Hospital Ottakring, Institute for Vascular Surgery

    RECRUITING

    Vienna, 1160, Austria

  • Hospital Ramon Y Cajal

    RECRUITING

    Madrid, Spain

  • IRCCS Ospedale San Raffaele, Chirurgia Vascolare

    RECRUITING

    Milan, 20132, Italy

  • Inselspital Bern, Universitätsklinik für Gefässchirurgie

    NOT_YET_RECRUITING

    Bern, 3010, Switzerland

  • Jessa Ziekenhuis

    RECRUITING

    Hasselt, 3500, Belgium

  • Klinikum der Technischen Universität München

    RECRUITING

    München, 81675, Germany

  • Martin Austermann

    COMPLETED

    Münster, 48145, Germany

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • National Institute of Cardiology Warzwa

    RECRUITING

    Warsaw, 04-628, Poland

  • Oklahoma Heart

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert

    RECRUITING

    Clermont-Ferrand, 63003, France

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • UCSD Medical Center Hillcrest

    RECRUITING

    La Jolla, California, 92037, United States

  • Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde

    RECRUITING

    Ghent, 9000, Belgium

  • University Hospital Leipzig

    RECRUITING

    Leipzig, 04109, Germany

  • University Hospital RWTH Aachen

    RECRUITING

    Aachen, 52074, Germany

  • University of Bologna, IRCCS S. Orsola Hospital,

    RECRUITING

    Bologna, 40138, Italy

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

  • VUMC Amsterdam

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Vascular Endovascular Surgery University of Perugia;

    NOT_YET_RECRUITING

    Perugia, 06100, Italy

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