Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study
Sponsor
Cook Group Incorporated (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT02577562
Collaborator
(none)
15
Study Details
Study Description
Brief Summary
The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Expanded Access
Official Title:
Zenith® Fenestrated AAA Endovascular Graft Clinical Study
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
Exclusion Criteria:
-
Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
-
Renal artery stenosis greater than 50 percent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
| 2 | Shands Hospital | Gainesville | Florida | United States | 32610 |
| 3 | University of Florida | Gainesville | Florida | United States | 32610 |
| 4 | The Indiana Heart Hospital | Indianapolis | Indiana | United States | 46250 |
| 5 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 6 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 7 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
| 8 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 9 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 10 | NYU Medical Center | New York | New York | United States | 10016 |
| 11 | University of North Carolina Hospital | Chapel Hill | North Carolina | United States | 27599 |
| 12 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 13 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 14 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 15 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Cook Group Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT02577562
Other Study ID Numbers:
- 04-541 CA
First Posted:
Oct 16, 2015
Last Update Posted:
Nov 24, 2017
Last Verified:
Nov 1, 2017