Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
- Conditions
- Aortic Aneurysm, Abdominal
- Interventions
- Device: Endurant Stent Graft System
- Registration Number
- NCT01379222
- Lead Sponsor
- Medtronic Cardiovascular
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ENGAGE PAS De Novo Subjects Endurant Stent Graft System 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).
- 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
Trial Locations
- Locations (24)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
University of Pittsburgh Medical Center UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, 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
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Medical Center of Central Georgia (MCCG)
🇺🇸Macon, Georgia, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Sanford Medical Center Fargo
🇺🇸Fargo, North Dakota, United States
WakeMed Health & Hospitals
🇺🇸Raleigh, North Carolina, United States
Stanford Hospital & Clinics
🇺🇸Stanford, California, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Physicians Regional Medical Center
🇺🇸Knoxville, Tennessee, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Parkwest Medical Center
🇺🇸Knoxville, Tennessee, United States