Fenestrated AAA Endovascular Graft Post-Approval Study

Abdominal Aortic Aneurysm (AAA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990950
• Other study ID #: 11-005
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: October 12, 2020

Study information

• Verified date: September 2021
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	University of California-Davis	Sacramento	California
United States	Wake Forest University Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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% ,	5 years