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Zenith® p-Branch® Endovascular Graft Pivotal Study
Recruiting
Trial ID: NCT02396199
Purpose
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety
and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium
iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Official Title
Zenith® p-Branch® Pivotal Study
Stanford Investigator(s)
Venita Chandra
Clinical Professor, Surgery - Vascular Surgery Clinical Professor (By courtesy), Neurosurgery
Jason T. Lee, MD
Professor of Surgery (Vascular Surgery)
Eligibility
Inclusion Criteria:
- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic
diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion Criteria:
- Age <18 years
- Life expectancy <2 years
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Inability or refusal to give informed consent by the patient or a legally authorized
representative
- Unwilling or unable to comply with the follow-up schedule
- Simultaneously participating in another investigative device or drug study. (The
patient must have completed the primary endpoint of any previous study at least 30
days prior to enrollment in this study.)
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan
Intervention(s):
device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305