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

Conditions
Abdominal Aortic Aneurysms
Aorto-iliac Aneurysms
Juxtarenal Aneurysms
Registration Number
NCT02577562
Lead Sponsor
Cook Group Incorporated
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
APPROVED_FOR_MARKETING
Sex
All
Target Recruitment
Not specified
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

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (15)

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

🇺🇸

Pittsburgh, Pennsylvania, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

The Indiana Heart Hospital

🇺🇸

Indianapolis, Indiana, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Shands Hospital

🇺🇸

Gainesville, Florida, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

Mayo Clinic Rochester

🇺🇸

Rochester, Minnesota, United States

Dartmouth Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

NYU Medical Center

🇺🇸

New York, New York, United States

University of Massachusetts Medical School

🇺🇸

Worcester, Massachusetts, United States

Barnes-Jewish Hospital

🇺🇸

Saint Louis, Missouri, United States

University of North Carolina Hospital

🇺🇸

Chapel Hill, North Carolina, United States

Harborview Medical Center

🇺🇸

Seattle, Washington, United States

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

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