Zenith® p-Branch® OTS Multicenter Study

Study ID
12-002

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital

Contact


Principal Investigator

Official Title

Zenith® p-Branch® Multicenter Study

Brief Overview


The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical
experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the
treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).

Participant 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