Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Eligibility Criteria
Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. 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 Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 2 years 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months 4. Inability or refusal to give informed consent by the patient or legally authorized representative 5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging 6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study