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| Sponsor: | Cook |
|---|---|
| Information provided by: | Cook |
| ClinicalTrials.gov Identifier: | NCT00875563 |
Purpose
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
| Condition | Intervention |
|---|---|
|
Abdominal Aortic Aneurysms Aorto-iliac Aneurysms Juxtarenal Aneurysms |
Device: Zenith(R) Fenestrated AAA Endovascular Graft |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft |
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Endovascular Repair
|
Device: Zenith(R) Fenestrated AAA Endovascular Graft
The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rachel Bell, PhD, RAC | 800-356-9208 | rbell@medinst.com |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Darren Schneider 415-353-4366 | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Anthony Lee, MD 352-273-5484 Anthony.lee@surgery.ufl.edu | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Christopher Kwolek 617-724-6101 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Gregorio Sicard 314-362-7841 | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Mark Farber 919-966-3391 | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Sean Lyden 216-444-3581 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Ronald M. Fairman, MD, FACS 215-614-0308 ron.fairman@uphs.upenn.edu | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Michel S. Makaroun, MD 412-802-3028 makarounms@upmc.edu | |
| Study Director: | Roy Greenberg, MD | Cleveland Clinic |
More Information
| Responsible Party: | Cook Incorporated ( Tonya Thurman ) |
| Study ID Numbers: | 04-541, 370015, FNCT |
| Study First Received: | February 19, 2009 |
| Last Updated: | January 12, 2010 |
| ClinicalTrials.gov Identifier: | NCT00875563 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases |
Iliac Aneurysm Cardiovascular Diseases Aortic Aneurysm |
