Study Results
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View full resultsBasic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2010-03-31
2018-05-11
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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Arm 1
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Interventions
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Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
* Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter
Exclusion Criteria
* Life expectancy less than 2 years
* Pregnant or breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Less than 30 days beyond primary endpoint for other investigative drug or device 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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Karl Illig, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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Kaiser Permanente
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
Indiana Heart Hospital
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York University Hospital
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Tennessee Baptist Memorial Hospital
Memphis, Tennessee, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Hannover Medical School
Hanover, , Germany
St. Franziskus Hospital
Münster, , Germany
Klinikum Nürnberg Sud
Nuremberg, , Germany
Uniklinik Regensburg
Regensburg, , Germany
University Hospital Rostock
Rostock, , Germany
Hospital San Raffaele
Milan, , Italy
Morinomiya Hospital
Osaka, , Japan
Jikei University School of Medicine
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Malmö University Hospital
Malmo, , Sweden
St.George's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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10-001
Identifier Type: -
Identifier Source: org_study_id
NCT00923754
Identifier Type: -
Identifier Source: nct_alias
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