Fenestrated AAA Endovascular Graft Post-Approval Study

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm (AAA); Juxtarenal Aneurysm; Aorto-iliac Aneurysm
• Interventions: Device: Zenith® Fenestrated AAA Endovascular Graft

• Registration Number: NCT01990950
• Lead Sponsor: Cook Research Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Study Start: 2014-03
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Results First Submitted: 2021-08-17
• Results First Submitted QC: 2021-08-17
• Status Verified: 2021-09
• Results First Posted: 2021-09-14
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zenith® Fenestrated AAA Endovascular Graft	Zenith® Fenestrated AAA Endovascular Graft	-

Primary Outcome Measures

Name	Time	Method
Treatment Success : AAA Related Mortality	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% ,

Trial Locations

Locations (6)

Borgess Research Institute; 🇺🇸 Kalamazoo, Michigan, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

University of California-Davis; 🇺🇸 Sacramento, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Wake Forest University Health; 🇺🇸 Winston-Salem, North Carolina, United States

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States