NCT01379222

Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Aortic Aneurysm, Abdominal

Interventions

Type	Name	Description
DEVICE	Endurant Stent Graft System	The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.

Timeline

• Start date: 2011-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-06-23
• Last updated: 2021-10-29
• Results posted: 2019-02-04

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated device study