Endurant EVO

Endurant Evo US Clinical Trial

Endurant EVO [NCT02393716]

Description:  The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.


Device: Endurant Evo AAA Stent Graft System
Procedure: Endovascular aneurysm repair (EVAR)

Primary Investigator: Answini

Drug/Device Information
To demonstrate that the Endurant Evo AAA stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms
The Endurant Evo AAA stent graft system was designed to further expand EVAR applicability and improve access in patients with challenging anatomies
Lower profile delivery system, graft flexibility and limb design optimization
A 3-piece modular system which is engineered to help with placement accuracy and enhanced delivery system ergonomic features
Non-randomized
Medtronic Aortic and Peripheral Vascular
Major Inclusion and Exclusion
Subject is a suitable candidate for elective surgical repair of AAA
Infrarenal abdominal aortic or aortoiliac aneurysm
Aneurysm is >5 cm in diameter or aneurysm is 4 – 5 cm in diameter and has increased in size ≥ 0.5 cm within the previous 6 months
Can not have been previously treated for an abdominal aortic aneurysm
No myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft
No creatinine level > 2.00 mg/dl