Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-08-31
2025-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endovascular
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Interventions
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Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
* Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion Criteria
* Life expectancy \<2 years
* Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
* Inability or refusal to give informed consent by the patient or a legally authorized representative
* Unwilling or unable to comply with the follow-up schedule
* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan
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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Mark A Farber, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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University of Alabama Birmingham Hosptial
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center-Dignity Health
Phoenix, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Kaiser Permanente
San Francisco, California, United States
Stanford University Medical School
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Boca Raton Community Hospita
Boca Raton, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Minneapolis Heart Inst. Foundation
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Barnes Jewish Hospital Plaza
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
New York University - Langone Medical Center
New York, New York, United States
Mount Sinai Roosevelt
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UT Southwestern
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
The Methodist Hospital - Smith Tower
Houston, Texas, United States
Baylor Scott and White Research Institute
Irving, Texas, 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 and Statistical Analysis Plan
Other Identifiers
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14-09
Identifier Type: -
Identifier Source: org_study_id
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