Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

Not Applicable

Completed

Brief 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).

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)	5 years	Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness.

Secondary Outcome Measures

Name	Time	Method

Locations (24): Ronald Reagan UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Stanford Hospital & Clinics
🇺🇸
Stanford, California, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Bayfront Medical Center
🇺🇸
Saint Petersburg, Florida, United States
Medical Center of Central Georgia (MCCG)
🇺🇸
Macon, Georgia, United States
Mercy Hospital and Medical Center
🇺🇸
Chicago, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸
Springfield, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
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Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States