Study of Abdominal Aortic Aneurysm (a bulge in the aorta; known as AAA) repair.

What we are studying

You have been asked to consider participating in a clinical study because you have been diagnosed with an abdominal aortic aneurysm (a bulge in the aorta; known as AAA). The goal of this study is to evaluate the ongoing safety and effectiveness of the the AFX® System compared to other similar devices by collecting data on your condition and the devices. All of the devices that will be assessed in this study are approved by the FDA for the treatment of abdominal aortic aneurysms and are commercially available in the United States. The AFX®device is made by Endologix, Inc. and Endologix is the sponsor, that is, will be paying for the study. The other devices that will be used in the study are Gore® EXCLUDER® AAA Endoprosthesis, Medtronic The Endurant® II AAA Stent Graft System, and Cook Zenith Flex® AAA Endovascular Graft all of these devices are intended to be used for the treatment of abdominal aortic aneurysms.

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 - 90

Eligibility Criteria

  • Must have a minimum of 2 year life expectancy
  • Must have an infrarenal AAA who are assessed by the investigarot to be eligible for endovascular repair with the study devices.

What is involved

  • Follow-Up visits will include physical exams
  • Blood work
  • CT scans of abdomen and pelvis as standard of care after an AAA endovascular repair

Compensation

None

Contact Information

Study Coordinator
Rob Paris, RN, Study Coordinator
Email
rparis@wakehealth.edu
Phone
336-716-3296
Principal Investigator
Nitin Garg, 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.