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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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Zenith TX2 Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms or 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 diameter ≥ 5.0 cm
* 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
* Pregnant of breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Less than 30 days beyond primary endpoint for other investigative drug or device study
* Receiving home oxygen
* Myocardial infarction within the last 3 months
* Stroke within the last 3 months
* Diagnosed or suspected congenital degenerative collagen disease
* Systemic infection
* Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
* Allergy to polyester, polypropylene, nitinol, or gold
* Previous placement of a thoracic endovascular graft
* Prior open repair involving the descending thoracic aorta
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Karl Illig, MD
Role: PRINCIPAL_INVESTIGATOR
Dialysis Access Center
Locations
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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 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
Cooper University Hospital
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The 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
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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10-001 CA
Identifier Type: -
Identifier Source: org_study_id
NCT02319551
Identifier Type: -
Identifier Source: nct_alias
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