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NCT02577562 Clinical Trial

Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

Abdominal Aortic Aneurysms Clinical Trial

Official title:
Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT02577562
Other study ID # 04-541 CA
Secondary ID
Status Approved for marketing
Phase N/A
First received October 14, 2015
Last updated November 21, 2017

Study information
Verified date November 2017
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zenith® Fenestrated AAA Endovascular Graft
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

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Hospital Chapel Hill North Carolina
United States Cleveland Clinic Cleveland Ohio
United States Shands Hospital Gainesville Florida
United States University of Florida Gainesville Florida
United States The Indiana Heart Hospital Indianapolis Indiana
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States NYU Medical Center New York New York
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Rochester Minnesota
United States Barnes-Jewish Hospital Saint Louis Missouri
United States University of California, San Francisco San Francisco California
United States Harborview Medical Center Seattle Washington
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

United States, 

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