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

May 8, 2026 updated by: Rijnstate Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69002
        • Recruiting
        • HCL Lyon
        • Principal Investigator:
          • A. Millon, MD
      • Marseille, France, 13285
        • Recruiting
        • Saint Joseph Marseille
        • Principal Investigator:
          • N. Valerio, MD
      • Nîmes, France, 30000
        • Recruiting
        • Les Franciscaines
        • Principal Investigator:
          • N. Louis, MD
  • Germany
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Osp. S.Orsola Malpighi - Bologna
        • Contact:
          • M Prof. Gargiulo, PhD
    • Metropolitan City of Genoa
      • Genova, Metropolitan City of Genoa, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Prof. G. Pratesi
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Recruiting
        • Rijnstate Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • MMPJ Reijnen, MD, PhD
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Ziekenhuis
        • Contact:
          • Ph.W.M. Cuypers
    • North Holland
      • Alkmaar, North Holland, Netherlands, 1815 JD
        • Not yet recruiting
        • Noordwest ziekenhuis
        • Contact:
          • Dr. Cagdas Unlu
      • Haarlem, North Holland, Netherlands, 2000 AK
        • Not yet recruiting
        • Spaarne Gasthuis
        • Contact:
          • Dr. Maarten Truijers
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic De Barcelona
        • Principal Investigator:
          • V Riambau, MD
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
          • Dr Gabriel C. Inaraja Perez
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Dr Marzo Alvarez
  • Switzerland
      • Morges, Switzerland, 1110
        • Recruiting
        • EHC-Hôpital de Morges
        • Principal Investigator:
          • F Saucy, MD
  • United Kingdom
      • Glasgow, United Kingdom
        • Recruiting
        • Queen Elizabeth University Hospital, Glasgow
        • Principal Investigator:
          • M Hennessy, MD
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
          • P. Dr. Walker, MD
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St. George's Hospital
        • Contact:
          • I Prof. Loftus, MD PhD
      • London, United Kingdom
        • Recruiting
        • St. Mary's Hospital
        • Principal Investigator:
          • C. Bicknell, MD
  • United States
    • Arkansas
      • Washington, Arkansas, United States, 27962
        • Recruiting
        • Washington Regional Medical Center
        • Principal Investigator:
          • R. Wood, MD
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mt Sinai Med Ctr
        • Principal Investigator:
          • M Ayad, MD
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola
        • Contact:
          • P. Dr. Halandras, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Henry Ford Hospital
        • Contact:
          • Dr. Mitchel Weaver
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont University Hospital
        • Principal Investigator:
          • O.W. Brown, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Alina Health
        • Principal Investigator:
          • J. Jim, MD
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Recruiting
        • University of Missouri
        • Principal Investigator:
          • T. Vogel, MD
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital
        • Principal Investigator:
          • L Sanchez, MD
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Medical Center
        • Principal Investigator:
          • Beckerman, MD
    • New York
      • Buffalo, New York, United States, 14214
        • Recruiting
        • Sisters of Charity Hospital
        • Principal Investigator:
          • P Anain, MD
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Principal Investigator:
          • A. Tassiopoulos, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart& Vascular
        • Principal Investigator:
          • R. Mendez, MD
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital
        • Principal Investigator:
          • B. Aplin, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17036
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health/Holston Valley
        • Principal Investigator:
          • R. Allen, MD
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Recruiting
        • Virginia Commonwealth University (VCU)
        • Principal Investigator:
          • Newton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
Device: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
Active Comparator: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors
Device: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint at on proximal seal outcomes
Time Frame: 1 year follow-up

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).
1 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from migration
Time Frame: 1 year follow-up
Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging)
1 year follow-up
Freedom from type IA endoleak
Time Frame: 1 year follow-up
Freedom from type IA endoleak
1 year follow-up
Freedom from aneurysm sac growth
Time Frame: 1 year follow-up
Aneurysm sac growth ≥5 mm (compared to 1-month imaging).
1 year follow-up
Freedom from neck dilatation ≥ 3 mm
Time Frame: 1 year follow-up
Neck dilatation ≥ 3 mm (compared to 1-month imaging).
1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

Medtronic

Investigators

  • Principal Investigator: MMPJ Reijnen, Prof. Dr., Rijnstate, Arnhem, the Netherlands
  • Principal Investigator: K. Donas, Prof. Dr., Asklepios Clinic Langen, Langen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2033

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1968

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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