Status:
ACTIVE_NOT_RECRUITING
Zenith® Fenestrated+ Clinical Study
Lead Sponsor:
Cook Research Incorporated
Conditions:
Aortic Aneurysm, Abdominal
Juxtarenal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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-Expan...
Eligibility Criteria
Inclusion
- Include Criteria:
- 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
- Exclusion Criteria:
- 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
- Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
- Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
Exclusion
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2031
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04875429
Start Date
December 8 2023
End Date
November 1 2031
Last Update
January 8 2026
Active Locations (32)
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1
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States, 35294
2
UC San Diego
La Jolla, California, United States, 92037
3
University of Southern California
Los Angeles, California, United States, 90031
4
Stanford Hospitals and Clinics
Stanford, California, United States, 94305