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Can tiny screws make aneurysm repair safer for wide necks?

NCT ID NCT05484115

Disease control Sponsor: Rijnstate Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 standard stent-graft repair (EVAR) to a technique that adds small metal anchors (Heli-FX EndoAnchors) to secure the graft in patients with wide-neck abdominal aortic aneurysms. About 300 adults with aneurysms and a neck diameter between 28-32 mm will be randomly assigned to one of the two procedures. The goal is to see if the anchors reduce leaks, graft movement, or aneurysm growth over time.

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 system (small metal screws used to secure a stent graft in place during aneurysm repair)
What this could lead to
If successful, this approach could reduce the risk of leaks or graft movement in people with wide-neck aneurysms, potentially improving long-term safety of the repair.
What could go wrong
This is a relatively early-stage randomized trial, and the added anchors may not significantly improve outcomes over standard repair. There are also risks of vessel injury or device complications.

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 300 people

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

Started

May 2023

Expected to finish

Apr 2033

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: * Age 18 years or older * Provided written informed consent * Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating * Elective repair * Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices * Infrarenal neck diameter ≥ 28 mm and ≤32 mm * Proximal neck length ≥10mm Exclusion Criteria: * Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system * Planned use of AUI main body device * Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study. * Patient with eGFR \< 30 ml/min/1.73m2 before the intervention * Patient's life expectancy \<2 years as judged by the investigator * Patient has a psychiatric or other condition that may interfere with the study * Patient has a known allergy to any device component * Patients with a systemic infection who may be at increased risk of endovascular graft infection. * Patient has a coagulopathy or uncontrolled bleeding disorder * Patient has a ruptured, leaking, or mycotic aneurysm * Patient is not eligible for standard EVAR * Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months * Patient is pregnant (Female patients of childbearing potential only) * Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure. * Patient has previously been treated with stent grafts in the aorto-iliac arteries

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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

    36 sites in 8 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Alina Health

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Asklepios Klinik Langen

    RECRUITING

    Langen, Hesse, 63225, Germany

  • Ballad Health/Holston Valley

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Barnes-Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Beaumont University Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Catharina Ziekenhuis

    RECRUITING

    Eindhoven, Netherlands

  • EHC-Hôpital de Morges

    RECRUITING

    Morges, 1110, Switzerland

  • HCL Lyon

    RECRUITING

    Lyon, 69002, France

  • Henry Ford Hospital

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Miguel Servet

    NOT_YET_RECRUITING

    Zaragoza, 50009, Spain

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, Metropolitan City of Genoa, 16132, Italy

  • Leeds General Infirmary

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Les Franciscaines

    RECRUITING

    Nîmes, 30000, France

  • Loyola

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Mt Sinai Med Ctr

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • NC Heart& Vascular

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Noordwest ziekenhuis

    NOT_YET_RECRUITING

    Alkmaar, North Holland, 1815 JD, Netherlands

  • Osp. S.Orsola Malpighi - Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Penn State Health Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17036, United States

  • Promedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Queen Elizabeth University Hospital, Glasgow

    RECRUITING

    Glasgow, United Kingdom

  • Rijnstate hospital

    RECRUITING

    Arnhem, 6815 AD, Netherlands

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Robert Wood Johnson University Medical Center

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saint Joseph Marseille

    RECRUITING

    Marseille, 13285, France

  • Sisters of Charity hospital

    RECRUITING

    Buffalo, New York, 14214, United States

  • Spaarne Gasthuis

    NOT_YET_RECRUITING

    Haarlem, North Holland, 2000 AK, Netherlands

  • St. George's Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • St. Mary's Hospital

    RECRUITING

    London, United Kingdom

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Universitatsklinikum Frankfurt

    NOT_YET_RECRUITING

    Frankfurt, 60596, Germany

  • University Hospital Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65211, United States

  • Virginia Commonwealth University (VCU)

    RECRUITING

    Richmond, Virginia, 23284, United States

  • Washington Regional Medical Center

    RECRUITING

    Washington, Arkansas, 27962, United States

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