Overview

This trial is active, not recruiting.

Conditions abdominal aortic aneurysm, aorto-iliac aneurysm, juxtarenal aneurysm
Treatment zenith® fenestrated aaa endovascular graft
Sponsor Cook
Start date March 2014
End date January 2019
Trial size 21 participants
Trial identifier NCT01990950, 11-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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

Primary Outcomes

Measure
Treatment success : AAA related mortality
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated AAA Endovascular Graft Post-Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Cook.