RecruitingAortic Aneurysm, Abdominal

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

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this 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).

Sponsor: Rijnstate Hospital

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.