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Aortic Aneurysm, AbdominalHERCULESNCT05484115

Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

A study testing endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system and endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system in people with Aortic Aneurysm, Abdominal, run by Rijnstate Hospital at 36 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck diameters (≥ 28mm… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Aneurysm, Abdominal
What is being tested?
endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system and endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
36 sitesin 8 countries
Study dates
26 May 2023to Apr 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

36 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Suzanne Holewijn, PhD contact

0031880057282

herculestrial@rijnstate.nl

Daphne van der Veen, MSc contact

0031880057282

herculestrial@rijnstate.nl

36 sites in 8 countries

United States16 sites, 16 recruiting

  • Sisters of Charity hospital

    Buffalo, New York, 14214

    P Anain, MD

    Recruiting

  • University of Missouri

    Columbia, Missouri, 65211

    T. Vogel, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Dr. Mitchel Weaver

    Not yet recruiting

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17036

    Dr. Faisal Aziz, MD, faziz@pennstatehealth.psu.edu

    Recruiting

  • Ballad Health/Holston Valley

    Kingsport, Tennessee, 37660

    R. Allen, MD

    Recruiting

  • Loyola

    Maywood, Illinois, 60153

    P. Dr. Halandras, MD

    Recruiting

  • Mt Sinai Med Ctr

    Miami Beach, Florida, 33140

    M Ayad, MD

    Recruiting

  • Alina Health

    Minneapolis, Minnesota, 55407

    J. Jim, MD

    Recruiting

  • Robert Wood Johnson University Medical Center

    New Brunswick, New Jersey, 08901

    Beckerman, MD

    Recruiting

  • NC Heart& Vascular

    Raleigh, North Carolina, 27607

    R. Mendez, MD

    Recruiting

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia, 23284

    Newton, MD

    Recruiting

  • Beaumont University Hospital

    Royal Oak, Michigan, 48073

    O.W. Brown, MD

    Recruiting

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

    L Sanchez, MD

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    A. Tassiopoulos, MD

    Recruiting

  • Promedica Toledo Hospital

    Toledo, Ohio, 43606

    B. Aplin, MD

    Recruiting

  • Washington Regional Medical Center

    Washington, Arkansas, 27962

    R. Wood, MD

    Recruiting

Other trials in United States

Netherlands4 sites, 4 recruiting

  • Noordwest ziekenhuis

    Alkmaar, North Holland, 1815 JD

    Dr. Cagdas Unlu

    Not yet recruiting

  • Rijnstate hospital

    Arnhem, 6815 AD

    Suzanne Holewijn, PhD, 0880057282, herculestrial@rijnstate.nl

    Daphne van der Veen, MSc, 0880057282, herculestrial@rijnstate.nl

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Ph.W.M. Cuypers

    Recruiting

  • Spaarne Gasthuis

    Haarlem, North Holland, 2000 AK

    Dr. Maarten Truijers

    Not yet recruiting

Other trials in Netherlands

United Kingdom4 sites, 4 recruiting

  • Queen Elizabeth University Hospital, Glasgow

    Glasgow

    M Hennessy, MD

    Recruiting

  • Leeds General Infirmary

    Leeds, LS1 3EX

    P. Dr. Walker, MD

    Recruiting

  • St. George's Hospital

    London, SW17 0QT

    I Prof. Loftus, MD PhD

    Recruiting

  • St. Mary's Hospital

    London

    C. Bicknell, MD

    Recruiting

Other trials in United Kingdom

France3 sites, 3 recruiting

  • HCL Lyon

    Lyon, 69002

    A. Millon, MD

    Recruiting

  • Saint Joseph Marseille

    Marseille, 13285

    N. Valerio, MD

    Recruiting

  • Les Franciscaines

    Nîmes, 30000

    N. Louis, MD

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt, 60596

    Prof. Dr. med. Kyriakos Oikonomou, Prof. MD, +49 069 6301 4136, kyriakos.oikonomou@unimedizin-ffm.de

    Tanja Dietrich, tanja.dietrich@unimedizin-ffm.de

    Not yet recruiting

  • Asklepios Klinik Langen

    Langen, Hesse, 63225

    Prof. Dr. med. Konstantinos Donas, MD PhD, 0049 06103 9 12-0, k.donas@asklepios.com

    Anja Bukvarevic, a.bukvarevic@asklepios.com

    Recruiting

  • University Hospital Leipzig

    Leipzig, 04103

    Dr. Schmidt, MD PhD, 0049 341 9720657, Andrej.Schmidt@medizin.uni-leipzig.de

    Steffi Anding, Steffi.Anding@medizin.uni-leipzig.de

    Recruiting

Other trials in Germany

Spain3 sites, 3 recruiting

  • Hospital Clinic de Barcelona

    Barcelona

    V Riambau, MD

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

    Dr Gabriel C. Inaraja Perez

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Dr Marzo Alvarez

    Not yet recruiting

Other trials in Spain

Italy2 sites, 2 recruiting

  • Osp. S.Orsola Malpighi - Bologna

    Bologna, 40138

    M Prof. Gargiulo, PhD

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, Metropolitan City of Genoa, 16132

    Prof. G. Pratesi

    Recruiting

Other trials in Italy

Switzerland1 site, 1 recruiting

  • EHC-Hôpital de Morges

    Morges, 1110

    F Saucy, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: Randomized Controlled Clinical Trial on the Application of Heli-FX EndoAnchors in Conjunction With the Endurant II/IIs Endograft in Infrarenal Aortic Aneurysms With a Wide Infrarenal Neck (HERCULES Trial)

The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).

Read the detailed description

HERCULES is an investigator driven trial and a collaborative research project with Medtronic.

Design; Prospective, post-market, global, multicenter, randomized (1:1), two-arm, superiority trial

Up to 300 subjects will be recruited in up to 40 sites in Europe and the US. All subjects shall be followed per local societal guidelines and per the Endurant II/IIs and Heli-FX EndoAnchor instruction for use (IFU) recommendations for post-implant follow-up and CT-imaging, with expected assessments at baseline, index procedure(s), 1-month, and annually at 1, 2, 3, 4, and 5 years post-index procedure.

Devices used in HERCULES include the Endurant II/IIs stent graft system (EVAR arm) and the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System (ESAR arm)

This study is being conducted to collect clinical evidence from treatment of patients with infrarenal AAA having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm), comparing clinical outcomes with treatment of the AAA with the Endurant II/IIs stent graft in conjunction with Heli-FX EndoAnchors to treatment of the AAA with the Endurant II/IIs stent graft alone. Though both the Endurant II/IIs stent graft and Heli-FX EndoAnchors are commercially approved in this indication, clinical evidence comparing these two treatments in patients with wide proximal aortic neck diameters is not currently available. Collecting clinical data specific to this patient population, including procedure and imaging data as well as long term outcomes, will provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal aortic neck diameters.

Being tested
endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system, endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Keywords
AAA, Endovascular treatment, Wide proximal neck, EndoAnchors, Infrarenal, EVAR (Endovascular aneurysm repair), ESAR (Endosuture aneurysm repair), Endurant II/IIs stent graft system, Heli-FX EndoAnchor system
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemDevice

    treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system

  • endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor systemDevice

    treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system

Study groups in NCT05484115
Study groupRoleWhat they receive
Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemActive comparatorNot described
Receives: Device: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with EndoanchorsActive comparatorNot described
Receives: Device: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoint at on proximal seal outcomes

    The primary endpoint is a composite endpoint based on core lab reported data from computed tomography (CT) with contrast imaging of freedom from:

    1. type IA endoleak and
    2. Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) and
    3. Aneurysm sac growth ≥5 mm (compared to 1-month imaging).

    Measured: 1 year follow-up

Secondary outcomes (4)

  1. Freedom from type IA endoleak

    Freedom from type IA endoleak

    Measured: 1 year follow-up

  2. Freedom from migration

    Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging)

    Measured: 1 year follow-up

  3. Freedom from aneurysm sac growth

    Aneurysm sac growth ≥5 mm (compared to 1-month imaging).

    Measured: 1 year follow-up

  4. Freedom from neck dilatation ≥ 3 mm

    Neck dilatation ≥ 3 mm (compared to 1-month imaging).

    Measured: 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start26 May 2023
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
HERCULES is a post-market, prospective, global, multicenter, randomized (1:1), two-arm, superiority trial designed to compare ESAR to standard EVAR clinical outcomes in treatment of infrarenal AAA in patients having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484115
Sponsor's protocol ID
2021-1968
Acronym
HERCULES
Status last verified
May 2026
First submitted
6 Jul 2022
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system and endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system in people with Aortic Aneurysm, Abdominal, run by Rijnstate Hospital at 36 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Netherlands, United Kingdom, France, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suzanne Holewijn, PhD (0031880057282, herculestrial@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint at on proximal seal outcomes (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484115.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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