The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
Up to 60 additional subjects may be enrolled in Continued Access phase of the study
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Age < 18 years
Life expectancy < 2 years
Pregnant, breast-feeding, or planning to become pregnant within 60 months
Inability or refusal to give informed consent by the patient or legally authorized representative
Cook Research Incorporated
Lead sponsor