Fenestrated AAA Endovascular Graft Post-Approval Study

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.

Completed

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Key information

Conditions

Abdominal Aortic Aneurysm (AAA) Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Aorto-iliac Aneurysm Cardiovascular Diseases Iliac Aneurysm Juxtarenal Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis, Sacramento, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenith® Fenestrated AAA Endovascular Graft

Device

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 aneursyms having morphology suitable for endovascular repair

Primary outcomes

Treatment Success : AAA Related Mortality

Time frame: 5 years

patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Nov 25, 2013
Registry last updated: Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed