Study for Endovascular Repair of Abdominal Aortic Aneurysms

What we are studying

The purpose of this study is to collect long-term patient results for a device that has recently been approved for use by the Food and Drug Administration (FDA) in the U.S. The device is used to treat a bulge or aneurysm of the aortic or aorto-iliac arteries without open surgery.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Aortic or aortoiliac aneurysm with a diameter > 5 cm or with a history of growth > 0.5 cm per year
  • Or clinical indication for AAA repair
  • Non leaking/ruptured or symptomatic aneurysm
  • >18 years of age
  • Non pregnant or breastfeeding women
  • Normal kidney function

What is involved

  • Your doctor will determine if you can be in this study based on your medical history and the measurements of your aneurysm. Because this product is commercially available the treatment of your aneurysm with the Zenith Fenestrated AAA Endovascular Graft will be the same regardless of whether you participate in the study or not. If you are eligible to be in the study and if you agree to participate data will be collected to look at device performance once you are enrolled in the study. As part of your institution’s standard of care you will be asked to have regularly scheduled follow-up visits with your doctor. For the purposes of this study information from these follow-up visits will be collected for up to 5 years. Depending on your institution’s standard of care these visits may be scheduled to take place before hospital discharge; approximately 30 days; 6 months; 12 months and annually thereafter after an endovascular graft has been placed. During the follow-up visits with your doctor you may have a CT scan (a special X-ray) of your abdomen; an additional abdominal X-ray; an ultrasound image of your kidneys; blood tests; and a physical examination in accordance with standard of care.

Contact Information

Study Coordinator
Rob Paris, RN, CCRP
Email
rparis@wakehealth.edu
Phone
336-671-0697
Principal Investigator
Justin Hurie, M.D.

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.