Descending Thoracic Aortic Aneurysm Clinical Trial
— TX2 2PASOfficial title:
Zenith TX2® TAA Endovascular Graft Post-approval Study
| Verified date | May 2021 |
| Source | Cook Group Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.
| Status | Completed |
| Enrollment | 115 |
| Est. completion date | March 23, 2020 |
| Est. primary completion date | February 14, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or - Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or - Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter Exclusion Criteria: - Age less than 18 years - Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years) - Pregnant, breast-feeding, or planning on becoming pregnant within 24 months - Unwilling or unable to comply with the follow-up schedule - Inability or refusal to give informed consent - Simultaneously participating in another investigative device or drug study |
| Country | Name | City | State |
|---|---|---|---|
| Canada | London Health Sciences Centre | London | Ontario |
| United States | University of Michigan Hospital | Ann Arbor | Michigan |
| United States | University of Denver Colorado | Aurora | Colorado |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | University of Virginia Medical Center | Charlottesville | Virginia |
| United States | Baylor University Medical Center at Dallas | Dallas | Texas |
| United States | DFW Vascular Group | Dallas | Texas |
| United States | New York Hospital of Queens | Flushing | New York |
| United States | University of Florida | Gainesville | Florida |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | New York University | New York | New York |
| United States | Heart Care Midwest | Peoria | Illinois |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | The Heart Hospital Baylor Plano | Plano | Texas |
| United States | Strong Memorial Hospital | Rochester | New York |
| United States | Kaiser Permanente | San Francisco | California |
| United States | Harborview Medical Center | Seattle | Washington |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Iowa Heart Center | West Des Moines | Iowa |
| United States | University of Massachusetts | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Cook Research Incorporated |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality | Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm. | 5 years |