Engage PAS

Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)

Engage PAS [NCT01379222]

Description: The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.

The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).


Device: Endurant Stent Graft System

Primary Investigator: Answini

Drug/Device Information
Post market, non-randomized, single arm, prospective post approval study
Endurant Stent Graft System (endovascular treatment of infrarenal abdominal aortic aneurysms)
Medtronic