Zenith p-Branch Pivotal Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Pararenal Or Juxtarenal Abdominal Aortic Aneurysm
  • Age: Between 18 Year(s) - 120 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
  • Subjects who have pararenal or juxtarenal AAA =5.0 cm in diameter or 2 times the normal aortic diameter
  • Subjects with pararenal or juxtarenal AAA with history of growth =0.5 cm/year;
  • Subjects with 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

You may not be eligible for this study if the following are true:

    1. Subjects who are younger than 18 years old
    2. Subjects has life expectancy less than 2 years
    3. Subjects who are pregnant or planning to become pregnant within 60 months
    4. Subjects unable or refusal to give informed consent by the patient or a legally authorized representative
    5. Subjects unwilling or unable to comply with the follow-up schedule
    6. Subjects simultaneously participating in another investigative device or drug study.
    7. Subjects with a leaking, ruptured, or mycotic aneurysm
    8. Subjects with active systemic infection
    9. Subjects with serum creatinine level >2.0 mg/dl
    10. Subjects does not have two viable renal arteries intended to be accommodated by the pivot fenestrations
    11. Subjects with significant surgical procedures (including endovascular repair) within 30 days before or after aneurysm repair
    12. Subjects with presence of a stent in any vessel to be accommodated with a fenestration that will interfere with deployment of the Zenith® p-Branch™ or stenting of renal and visceral vessels accommodated by a fenestration
    13. Subjects with previous endograft in the abdominal aorta
    14. Subjects who have bleeding, diathesis, or uncorrectable coagulopathy
    15. Subjects who refuses blood transfusion
    16. Subjects who have allergy to materials of the graft(s) or their delivery systems
    17. Subjects with anaphylactic reaction to contrast that cannot be adequately pre-medicated.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.