Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

Completed · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal

In brief

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).

Key facts

Study ID

NCT01379222

Run by

Medtronic Cardiovascular

People needed

178

Starts

2011-08-01

Expected to finish

2017-12-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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 — St. 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
• WakeMed Health & Hospitals — Raleigh, North Carolina, United States
• Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Sanford Medical Center Fargo — Fargo, North Dakota, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Lehigh Valley Hospital - Cedar Crest — Allentown, Pennsylvania, United States
• University of Pittsburgh Medical Center UPMC Shadyside — Pittsburgh, Pennsylvania, United States
• Physicians Regional Medical Center — Knoxville, Tennessee, United States
• Parkwest Medical Center — Knoxville, Tennessee, United States
• Baylor Jack and Jane Hamilton Heart and Vascular Hospital — Dallas, Texas, United States
• CHI Saint Luke's Health - Baylor Saint Luke's Medical Center — Houston, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Aurora Saint Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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