This trial is active, not recruiting.

Condition aortic aneurysm, abdominal
Treatment endurant stent graft system
Phase phase 4
Sponsor Medtronic Endovascular
Collaborator Duke Clinical Research Institute
Start date August 2011
End date August 2017
Trial size 178 participants
Trial identifier NCT01379222, 10012289


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).
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.

Primary Outcomes

Freedom from Aneurysm-related Mortality Rate (ARM) at 5 years (1826 days)
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age ≥18 years - Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System - Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information - Intention to electively implant the Endurant Stent Graft System - Ability and willingness to comply with the Clinical Investigational Plan (CIP). Exclusion Criteria: - High probability of non-adherence to physician's follow-up requirements - Current participation in a concurrent trial which may confound study results - Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.

Additional Information

Official title Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)
Principal investigator Marc Schermerhorn, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.