Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study
Zenith® Fenestrated AAA Endovascular Graft Clinical Study
1 other identifier
expanded_access
N/A
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2015
CompletedFirst Posted
Study publicly available on registry
October 16, 2015
CompletedNovember 24, 2017
November 1, 2017
October 14, 2015
November 21, 2017
Conditions
Interventions
The Zenith® 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 Criteria
You may qualify if:
- Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of California, San Francisco
San Francisco, California, 94143, United States
Shands Hospital
Gainesville, Florida, 32610, United States
University of Florida
Gainesville, Florida, 32610, United States
The Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NYU Medical Center
New York, New York, 10016, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2015
First Posted
October 16, 2015
Last Updated
November 24, 2017
Record last verified: 2017-11