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Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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).
What is being tested
- endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system (device)
- endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system (device)
Sponsor: Rijnstate Hospital · Participants: 300 · Started: May 26, 2023
Contact the study team
- Suzanne Holewijn, PhD · Phone: 0031880057282
- Daphne van der Veen, MSc · Phone: 0031880057282
Official record on ClinicalTrials.gov — NCT05484115
Locations in the U.S.
| Arkansas | Washington Regional Medical Center, Washington |
| Florida | Mt Sinai Med Ctr, Miami Beach |
| Illinois | Loyola, Maywood |
| Michigan | Henry Ford Hospital, Detroit (Not yet recruiting) Beaumont University Hospital, Royal Oak |
| Minnesota | Alina Health, Minneapolis |
| Missouri | University of Missouri, Columbia Barnes-Jewish Hospital, St Louis |
| New Jersey | Robert Wood Johnson University Medical Center, New Brunswick |
| New York | Sisters of Charity hospital, Buffalo Stony Brook University Medical Center, Stony Brook |
| North Carolina | NC Heart& Vascular, Raleigh |
| Ohio | Promedica Toledo Hospital, Toledo |
| Pennsylvania | Penn State Health Milton S. Hershey Medical Center, Hershey |
| Tennessee | Ballad Health/Holston Valley, Kingsport |
| Virginia | Virginia Commonwealth University (VCU), Richmond |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.