Can tiny screws make aneurysm repair safer for wide necks?

NCT ID NCT05484115

Recruiting now Disease control Sponsor: Rijnstate Hospital Source: ClinicalTrials.gov ↗

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.

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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

Contacts and locations

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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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