Fenestrated AAA Endovascular Graft Post-Approval Study

September 15, 2021 updated by: Cook Research Incorporated

Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California-Davis
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27102
        • Wake Forest University Health
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zenith® Fenestrated AAA Endovascular Graft
Device: Zenith® Fenestrated AAA Endovascular Graft
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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% ,
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Research Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

October 12, 2020

Study Completion (ACTUAL)

October 12, 2020

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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