EASYII - A Post-Market Clinical Follow-up Study (PMCF) in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System - Imaging Cohort
The objective of the study is to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time as well as to evaluate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
• 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