Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
This study is a prospective, randomized, multi-center study, intended to evaluate the
outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The
study is designed to compare the anatomically stabilized AFX Endograft System to a reference
group of proximally fixated EVAR devices. Patients will be randomized between the two
groups.
Randomization will be 1:1. Each investigator will select one comparator device of their
choice before enrolling the first patient. The study will sequentially evaluate
non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this
study.
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SC CTSI