Recruiting

EVAR vs. ESARComparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

Sponsor:

Rijnstate Hospital

Code:

NCT05484115

Conditions

Aortic Aneurysm, Abdominal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

Study Details

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).

Conditions

Aortic Aneurysm, Abdominal

Study ID

NCT05484115

Start date

May 26, 2023

Status verified date

May, 2026

Completion date

Apr, 2033

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system

active comparator: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors

Interventions

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

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

Primary outcome measure

Composite endpoint at on proximal seal outcomes [ Time Frame: 1 year follow-up ]

Central Contacts and Locations

Central contacts

Suzanne Holewijn, PhD

0031880057282 herculestrial@rijnstate.nl

Daphne van der Veen, MSc

0031880057282 herculestrial@rijnstate.nl

Locations

Washington Regional Medical Center

Recruiting

Washington, Arkansas, United States, 27962

Principal Investigator:

R. Wood, MD

Mt Sinai Med Ctr

Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator:

M Ayad, MD

Loyola

Recruiting

Maywood, Illinois, United States, 60153

Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Principal Investigator:

O.W. Brown, MD

Alina Health

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

J. Jim, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Principal Investigator:

T. Vogel, MD

Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

L Sanchez, MD

Robert Wood Johnson University Medical Center

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Beckerman, MD

Sisters of Charity hospital

Recruiting

Buffalo, New York, United States, 14214

Principal Investigator:

P Anain, MD

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator:

A. Tassiopoulos, MD

NC Heart& Vascular

Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator:

R. Mendez, MD

Promedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Principal Investigator:

B. Aplin, MD

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17036

Contacts

Dr. Faisal Aziz, MD

faziz@pennstatehealth.psu.edu

Ballad Health/Holston Valley

Recruiting

Kingsport, Tennessee, United States, 37660

Principal Investigator:

R. Allen, MD

Virginia Commonwealth University (VCU)

Recruiting

Richmond, Virginia, United States, 23284

Principal Investigator:

Newton, MD

More Information

Sponsor

Rijnstate Hospital

Last update posted

May 11, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rijnstate Hospital on 2026-05-11.