infrarenal aortic aneurysm widening of abdominal aorta
Conditions
Interventions
None listed
Sponsors
JOTEC GmbH
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: * Age >= 65 * Patient must have an o infrarenal aortic aneurysm with diameter >= 50 mm in females and >= 55 mm in males, or o 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: • Rate of 30-day mortality Primary Imaging Endpoint: • Quantifying stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time at 30 day follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| • Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans at prior to discharge, 6, 12, and optionally at 24 months follow-up • Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans at prior to discharge, 6, 12, and optionally at 24 months follow-up • Rate of all-cause mortality in perioperative period (24 h) • Rate of all-cause mortality at 12, 24, 36 and 60 months • Rate of aneurysm-related mortality at 30 days, 12, 24, 36 and 60 months • Rate of aneurysm rupture-related mortality at 30 days, 12, 24, 36 and 60 months • Rate of patients with aneurysm rupture at 30 days, 12, 24, 36 and 60 months • Rate of patients with technical success 24 h after the intervention • Rate of patients with clinical success at 12 months • Rate of patients with any reintervention at 30 days, 12, 24, 36 and 60 months • Rate of patients with reintervention-free survival at 12 months follow-up • Rate of patients with primary E-tegra Stent Graft limb patency at 30 days, 12, 24, 36 and 60 months • Rate of patients with secondary E-tegra Stent Graft limb patency at 30 days, 12, 24, 36 and 60 months • Rate of patients with stable aneurysm size on CTA scan at 12 and 60 months • Rate of patients with decreasing aneurysm size on CTA scan (= 5 mm in maximum diameter) at 12 and 60 months • Rate of patients with stable AAA volume on CTA scan at 12 and 60 months • Rate of patients with decreasing AAA volume on CTA scan (= 5 %) at 12 and 60 months • Rate of patients with major adverse events at 30 days, 12, 24, 36, and 60 months • Rate of patients with Type Ia endoleak at 12 and 60 months • Rate of patients with Type Ib endoleak at 12 and 60 months • Rate of patients with Type II endoleak at 12 and 60 months • Rate of patients with Type III endoleak at 12 and 60 months • Rate of patients with Type IV endoleak at 12 and 60 months • Rate of patients wi | — |
Countries
Netherlands
Outcome results
None listed