Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
105 participants
INTERVENTIONAL
2023-12-08
2031-08-31
Brief Summary
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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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Aortic abdominal aneurysm
Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Endovascular aneurysm repair
Interventions
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Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Endovascular aneurysm repair
Eligibility Criteria
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Exclusion Criteria
2. Life expectancy \< 2 years
3. Pregnant, breast-feeding, or planning to become pregnant within 60 months
4. Inability or refusal to give informed consent by the patient or legally authorized representative
5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
18 Years
ALL
No
Sponsors
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Cook Research Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Gustavo Oderich, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
UC San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Stanford Hospitals and Clinics
Stanford, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York University Langone Medical Center
New York, New York, United States
Columbia University Irving Medical Center/NY Presbyterian Hospital
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Holston Valley Hospital
Kingsport, Tennessee, United States
Ut Southwestern
Dallas, Texas, United States
Memorial Hermann Texas Medical Center/UT Health
Houston, Texas, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
St Thomas' Hospital
London, , United Kingdom
Countries
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Other Identifiers
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17-07
Identifier Type: -
Identifier Source: org_study_id