Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
HERCULES
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)
1 other identifier
interventional
300
8 countries
37
Brief 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 and ≤ 32mm).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2033
March 17, 2026
March 1, 2026
5.9 years
July 6, 2022
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
1 year follow-up
Secondary Outcomes (4)
Freedom from type IA endoleak
1 year follow-up
Freedom from migration
1 year follow-up
Freedom from aneurysm sac growth
1 year follow-up
Freedom from neck dilatation ≥ 3 mm
1 year follow-up
Study Arms (2)
Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
ACTIVE COMPARATOREndosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors
ACTIVE COMPARATORInterventions
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rijnstate Hospitallead
- Medtroniccollaborator
Study Sites (37)
Washington Regional Medical Center
Washington, Arkansas, 27962, United States
Mt Sinai Med Ctr
Miami Beach, Florida, 33140, United States
Loyola
Maywood, Illinois, 60153, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Alina Health
Minneapolis, Minnesota, 55407, United States
University of Missouri
Columbia, Missouri, 65211, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, 08901, United States
Sisters of Charity hospital
Buffalo, New York, 14214, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
NC Heart& Vascular
Raleigh, North Carolina, 27607, United States
Promedica Toledo Hospital
Toledo, Ohio, 43606, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17036, United States
Ballad Health/Holston Valley
Kingsport, Tennessee, 37660, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23284, United States
HCL Lyon
Lyon, 69002, France
Saint Joseph Marseille
Marseille, 13285, France
Les Franciscaines
Nîmes, 30000, France
Asklepios Klinik Langen
Langen, Hesse, 63225, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60596, Germany
University Hospital Leipzig
Leipzig, 04103, Germany
IRCCS Ospedale Policlinico San Martino
Genova, Metropolitan City of Genoa, 16132, Italy
Osp. S.Orsola Malpighi - Bologna
Bologna, 40138, Italy
Noordwest ziekenhuis
Alkmaar, North Holland, 1815 JD, Netherlands
Spaarne Gasthuis
Haarlem, North Holland, 2000 AK, Netherlands
Rijnstate hospital
Arnhem, 6815 AD, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Ramon Y Cajal
Madrid, 28034, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
EHC-Hôpital de Morges
Morges, 1110, Switzerland
Queen Elizabeth University Hospital, Glasgow
Glasgow, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
St. George's Hospital
London, SW17 0QT, United Kingdom
St. Mary's Hospital
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MMPJ Reijnen, Prof. Dr.
Rijnstate, Arnhem, the Netherlands
- PRINCIPAL INVESTIGATOR
K. Donas, Prof. Dr.
Asklepios Clinic Langen, Langen, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
August 2, 2022
Study Start
May 26, 2023
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2033
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share