Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
NCT ID: NCT01379222
Last Updated: 2021-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
178 participants
INTERVENTIONAL
2011-08-31
2017-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ENGAGE PAS De Novo Subjects
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Schermerhorn, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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10012289
Identifier Type: -
Identifier Source: org_study_id