Fenestrated AAA Endovascular Graft Post-Approval Study

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm

In brief

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

Key facts

Study ID

NCT01990950

Run by

Cook Research Incorporated

People needed

21

Starts

2014-03-01

Expected to finish

2020-10-12

Last updated by the study team

2021-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
• aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

You may not qualify if…

• proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
• renal artery stenosis greater than 50 percent

Where it is running

• University of California-Davis — Sacramento, California, United States
• University of Colorado — Aurora, Colorado, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Wake Forest University Health — Winston-Salem, North Carolina, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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