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

RECRUITING
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18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:
* 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 Criteria:
* 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

DEVICE: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system, DEVICE: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

Aortic Aneurysm, Abdominal

AAA, Endovascular treatment, Wide proximal neck, EndoAnchors, Infrarenal, EVAR (Endovascular aneurysm repair), ESAR (Endosuture aneurysm repair), Endurant II/IIs stent graft system, Heli-FX EndoAnchor system

Suzanne Holewijn, PhD - herculestrial@rijnstate.nl
NA
NCT05484115

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