Fenestrated AAA Endovascular Graft Post-Approval Study

N/ACompletedNCT01990950

Cook Research Incorporated21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Aortic Aneurysm (AAA)Aorto-iliac Aneurysm Juxtarenal Aneurysm

Interventions

Zenith® Fenestrated AAA Endovascular GraftDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

Treatment Success : AAA Related Mortality

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% ,

Time frame: 5 years

Data from ClinicalTrials.gov

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