EASYII - E-tegra Stent Graft System - Imaging Cohort

In this study, patients will be observed who are treated with an aorto-iliac bifurcated or aorto-uni-iliac configuration of the E-tegra Stent Graft System for the treatment of an infrarenal aortic or aorto-iliac aneurysm. The E-tegra Stent Graft components will be implanted at the discretion of the treating physician according to the local protocols.

EASYII is an interventional, non-randomized, post-market, multicentre study. The EASYII study is conducted to further assess, within the scope of the intended purpose, the E-tegra Stent Graft, including the study specific additional exam (visit at 6 months). The patients will undergo ECG-gated CTA scans instead of static CTA scans at pre-operative planning, prior to discharge, 30 days, 6 months, 12 months in order to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time. An additional ECG-gated CTA scan may optionally be performed at 24 months if the stent fixation (barbs) and stent graft conformability continue up to the 12 months scan.

Inclusion criteria

• Age ≥ 65
• Patient must have an

• infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or
• infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year
• Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System
• Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 6 months, 12 months, and annually thereafter until 5 years follow-up
• Patient understands and has signed the Informed Consent Form prior to intervention
• Patient has a life expectancy of at least 5 years

Exclusion criteria

• Patient with severe calcification or thrombi in the proximal sealing zone
• Patient with infectious aneurysm
• Patient with inflammatory aneurysm
• Patient with pseudoaneurysm
• Patient with symptomatic aneurysm
• Patient with ruptured or traumatic aneurysm
• Patient with suprarenal, juxtarenal, or pararenal aneurysm
• Patient with aortic dissection
• Patient with a reversed conical neck that is defined as a > 3 mm distal increase over a 15 mm length
• Patient in which the E-tegra Stent Graft System is used in combination with proximal or distal extenders of another company.
• Patient who is planned to be treated with an adjunctive aortic bare metal stent or a fenestrated stent graft
• Patient who is planned to be treated with a chimney / chimneys in the renal or visceral vessels
• Patient who is planned to be treated with an iliac branch device or parallel grafts in the iliac vessels
• Patient with genetic connective tissue disease (e.g. Marfan syndrome or Ehlers-Danlos syndrome)
• Patient with eGFR < 45 ml/min/1.73 m2 before the intervention Patient had or planned to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the E-tegra Stent Graft System
• Patient with other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with a limited life expectancy of less than five years (i.e. heart failure, active malignancy (progressive, stable or partial remission))
• Patient who has been enrolled in another active clinical trial that does not allow inclusion in this trial