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

NCT ID: NCT02577562

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Abdominal Aortic Aneurysms Aorto-iliac Aneurysms Juxtarenal Aneurysms

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Shands Hospital

Gainesville, Florida, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

The Indiana Heart Hospital

Indianapolis, Indiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

NYU Medical Center

New York, New York, United States

Site Status

University of North Carolina Hospital

Chapel Hill, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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04-541 CA

Identifier Type: -

Identifier Source: org_study_id