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HERCULES Trial: Comparing EVAR and ESAR for Abdominal Aortic Aneurysms

This study, called HERCULES, is looking at two ways to treat abdominal aortic aneurysms (AAA), which are bulges in the main artery in your belly. It compares standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system to endosuture aneurysm repair (ESAR), which uses the same stent graft system along with the Heli-FX EndoAnchor system. This trial is for people with AAAs who have a wide proximal neck (the part of the artery near the aneurysm). The study aims to see which treatment leads to better outcomes related to how well the repair seals at the aneurysm's neck after one year. We are looking for up to 300 participants who are 18 years or older and meet specific anatomical requirements for these devices. The study status is currently unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to one of two treatment groups. Up to 300 people will participate across various locations in Europe and the US.
What's involved
You would have assessments at the beginning of the study, during the procedure, at 1 month, and then annually for 5 years after the procedure, including CT scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after their procedure, with the primary outcome measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05484115

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

Recruiting
NAAges 18+InterventionalTreatment
Rijnstate Hospital
~300 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemendosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

At a glance

Recruiting sites
31 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite endpoint at on proximal seal outcomes
Measured over 1 year follow-up

Conditions

Aortic Aneurysm, Abdominal

Explore related trials

Abdominal Aortic Aneurysm

Where it's being run

36 sites across 23 states
United Kingdom4
France3
Spain3
Michigan2
Missouri2
New York2
Germany2
North Holland2

Study leadership

  • MMPJ Reijnen, Prof. Dr. · PRINCIPAL_INVESTIGATOR · Rijnstate, Arnhem, the Netherlands
  • K. Donas, Prof. Dr. · PRINCIPAL_INVESTIGATOR · Asklepios Clinic Langen, Langen, Germany

Who to contact

Suzanne Holewijn, PhD
[email protected]
0031880057282
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Composite endpoint at on proximal seal outcomes1 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).