Aortic Aneurysm Clinical Trial
Official title:
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
NCT number | NCT02471781 |
Other study ID # | 10-001 CA |
Secondary ID | |
Status | Approved for marketing |
Phase | |
First received | |
Last updated |
Verified date | January 2020 |
Source | Cook Group Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.
Status | Approved for marketing |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Meets one of the following - 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: - Life expectancy less than 2 years - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
United States | Emory University | Atlanta | Georgia |
United States | Cooper University Hospital | Camden | New Jersey |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Ohio State University | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Indiana Heart Hospital | Indianapolis | Indiana |
United States | Methodist Hospital of Indiana | Indianapolis | Indiana |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | The Mount Sinai Hospital | New York | New York |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Cook Group Incorporated |
United States,
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