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

Who can take part

• 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

Who cannot take part

• 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)