Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Key facts
- Where
- Alkmaar, Arnhem, Eindhoven, and Haarlem, NetherlandsSee the 4 sites
Where in Netherlands
- Noordwest ziekenhuisAlkmaar, NetherlandsContact: Dr. Cagdas UnluNot yet recruiting
- Rijnstate HospitalArnhem, NetherlandsContact: Suzanne Holewijn, PhDTaking people
- Catharina ZiekenhuisEindhoven, NetherlandsContact: Ph.W.M. CuypersTaking people
- Spaarne GasthuisHaarlem, NetherlandsContact: Dr. Maarten TruijersNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Rijnstate Hospital
- Trial code
- NCT05484115
- Record updated
- 11 May 2026
- Original description
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).Read full original descriptionShow less
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).
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: Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months; 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; 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 with eGFR < 30 ml/min/1.73m2 before the intervention; Patient's life expectancy <2 years as judged by the investigator; 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 has a ruptured, leaking, or mycotic aneurysm; Patient is not eligible for standard EVAR; Patient is pregnant (Female patients of childbearing potential only).