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Fenestrated AAA Endovascular Graft Post-Approval Study

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zenith® Fenestrated AAA Endovascular Graft
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm (AAA) focused on measuring Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California-Davis
  • University of Colorado
  • Borgess Research Institute
  • Newark Beth Israel Medical Center
  • Wake Forest University Health
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zenith® Fenestrated AAA Endovascular Graft

Arm Description

Outcomes

Primary Outcome Measures

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% ,

Secondary Outcome Measures

Full Information

First Posted
November 18, 2013
Last Updated
September 15, 2021
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01990950
Brief Title
Fenestrated AAA Endovascular Graft Post-Approval Study
Official Title
Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 12, 2020 (Actual)
Study Completion Date
October 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm
Keywords
Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zenith® Fenestrated AAA Endovascular Graft
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Zenith® Fenestrated AAA Endovascular Graft
Intervention Description
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 Outcome Measure Information:
Title
Treatment Success : AAA Related Mortality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Wake Forest University Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27102
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fenestrated AAA Endovascular Graft Post-Approval Study

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