Fenestrated AAA Endovascular Graft Post-Approval Study
This trial is active, not recruiting.
|Conditions||abdominal aortic aneurysm, aorto-iliac aneurysm, juxtarenal aneurysm|
|Treatment||zenith® fenestrated aaa endovascular graft|
|Start date||March 2014|
|End date||January 2020|
|Trial size||21 participants|
|Trial identifier||NCT01990950, 11-005|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Sacramento, CA||University of California-Davis||no longer recruiting|
|Aurora, CO||University of Colorado||no longer recruiting|
|Kalamazoo, MI||Borgess Research Institute||no longer recruiting|
|Newark, NJ||Newark Beth Israel Medical Center||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Health||no longer recruiting|
|Madison, WI||University of Wisconsin Hospital and Clinics||no longer recruiting|
|Intervention model||single group assignment|
Treatment success : AAA related mortality
time frame: 5 years
All participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated AAA Endovascular Graft Post-Approval Study|
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