Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:July 2008
End Date:April 2024
Contact:Morgan Griffith
Email:morgan.griffith@cookmedical.com
Phone:800-468-1379

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Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion

The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a
clinical trial approved by US FDA to study the safety and effectiveness of the Zenith®
p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic
aneurysms.


Inclusion Criteria:

- Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter

- Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months

- Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

- Age < 18 years

- Life expectancy < 2 years

- Pregnant or breast feeding

- Inability or refusal to give informed consent

- Unwilling or unable to comply with the follow-up schedule

- Additional medical restrictions as specified in the Clinical Investigation Plan

- Additional anatomical restrictions as specified in the Clinical Investigation Plan
We found this trial at
2
sites
New York, New York 10025
Phone: 212-523-7460
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New York, New York 10032
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