Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Recruiting now · Not applicable
Conditions studied: Aortic Aneurysm, Abdominal
In brief
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).
Key facts
- Study ID
- NCT05484115
- Run by
- Rijnstate Hospital
- People needed
- 300
- Starts
- 2023-05-26
- Expected to finish
- 2033-04-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- St. Mary's Hospital — London, United Kingdom (enrolling)
- Mt Sinai Med Ctr — Miami Beach, Florida, United States (enrolling)
- Loyola — Maywood, Illinois, United States (enrolling)
- EHC-Hôpital de Morges — Morges, Switzerland (enrolling)
- Queen Elizabeth University Hospital, Glasgow — Glasgow, United Kingdom (enrolling)
- Leeds General Infirmary — Leeds, United Kingdom (enrolling)
- St. George's Hospital — London, United Kingdom (enrolling)
- Washington Regional Medical Center — Washington, Arkansas, United States (enrolling)
- Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)
- Alina Health — Minneapolis, Minnesota, United States (enrolling)
- University of Missouri — Columbia, Missouri, United States (enrolling)
- Barnes-Jewish Hospital — St Louis, Missouri, United States (enrolling)
- Robert Wood Johnson University Medical Center — New Brunswick, New Jersey, United States (enrolling)
- Sisters of Charity hospital — Buffalo, New York, United States (enrolling)
- Stony Brook University Medical Center — Stony Brook, New York, United States (enrolling)
- NC Heart& Vascular — Raleigh, North Carolina, United States (enrolling)
- Promedica Toledo Hospital — Toledo, Ohio, United States (enrolling)
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
- Ballad Health/Holston Valley — Kingsport, Tennessee, United States (enrolling)
- Virginia Commonwealth University (VCU) — Richmond, Virginia, United States (enrolling)
- HCL Lyon — Lyon, France (enrolling)
- Saint Joseph Marseille — Marseille, France (enrolling)
- Les Franciscaines — Nîmes, France (enrolling)
- Asklepios Klinik Langen — Langen, Hesse, Germany (enrolling)
- University Hospital Leipzig — Leipzig, Germany (enrolling)
Full record on ClinicalTrials.gov
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