Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Study Details
Study Description
Brief Summary
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year)
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An Informed Consent Form signed by Subject or legal representative
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Appropriate aortic anatomy to receive the TAMBE Device d
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Mayo Clinic Arizona | Scottsdale | Arizona | United States | 85259 |
| 3 | Keck Medical Center of USC | Los Angeles | California | United States | 90033 |
| 4 | Kaiser Permanente San Francisco Medical Center | San Francisco | California | United States | 94118 |
| 5 | Stanford University | Stanford | California | United States | 94305 |
| 6 | MedStar Health Research Institute - MedStar Washington Hospital | Washington | District of Columbia | United States | 20010 |
| 7 | University of Florida - Gainesville | Gainesville | Florida | United States | 32610 |
| 8 | University of South Florida | Tampa | Florida | United States | 33606 |
| 9 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
| 10 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 11 | Indiana University | Indianapolis | Indiana | United States | 46226 |
| 12 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 13 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 14 | University of Michigan - Cardiac Surgery | Ann Arbor | Michigan | United States | 48109 |
| 15 | Essentia Health | Duluth | Minnesota | United States | 55805 |
| 16 | Division of Vascular Surgery - Minneapolis Heart Institute | Minneapolis | Minnesota | United States | 55407 |
| 17 | Mayo Clinic - Rochester | Rochester | Minnesota | United States | 55905 |
| 18 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 19 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 20 | Mount Sinai West | New York | New York | United States | 10019 |
| 21 | Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 22 | University of Rochester | Rochester | New York | United States | 14627 |
| 23 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 24 | Sanger Heart & Vascular Institute | Charlotte | North Carolina | United States | 28203 |
| 25 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 26 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 27 | The Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
| 28 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 29 | UPP Heart and Vascular Institute | Pittsburgh | Pennsylvania | United States | 15213 |
| 30 | University of Tennessee -University Vascular Surgeons | Knoxville | Tennessee | United States | 37920 |
| 31 | Cardiothoracic and Vascular Surgeons, PA (CTVS) | Austin | Texas | United States | 78756 |
| 32 | Baylor Heart & Vascular Hospital | Dallas | Texas | United States | 75226 |
| 33 | University of Texas Southwestern | Dallas | Texas | United States | 75352 |
| 34 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 35 | The Methodist Hospital - Houston | Houston | Texas | United States | 77030 |
| 36 | University of Texas Health Science Center | Houston | Texas | United States | 77030 |
| 37 | Sentara Medical Group | Norfolk | Virginia | United States | 23507 |
| 38 | Carilion Clinic Hospitals | Roanoke | Virginia | United States | 24014 |
| 39 | University of Washington | Seattle | Washington | United States | 98195 |
| 40 | University of Wisconsin - Madison | Madison | Wisconsin | United States | 53792 |
| 41 | Aurora Health Care, Metro Inc. | Milwaukee | Wisconsin | United States | 53215 |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAA 17-01 Expanded Access