A Study to Assess Outcomes of Patients Treated with AFX System Compared to Other EVAR Devices

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 15-007054
    NCT ID: NCT02407457
    Sponsor Protocol Number: CP-0011

About this study

The purpose of this study is to evaluate Endologix AFX endovascular abdominal aortic aneurism system with anatomical fixation against other approved endovascular systems with proximal fixation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Male or female at least 18 years old
  • Subjects with minimum of 2 year life expectancy
  • Subjects have signed the informed consent document for data release
  • Subjects with abdominal aortic aneurysm and eligible for endovascular abdominal aortic aneurysm repair

Exclusion Criteria

  • Currently participating in another study where primary endpoint has not been reached yet
  • Known allergy to any of the device components
  • Pregnant (females of childbearing potential only)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Warner Oldenburg, M.D.

Closed for enrollment

Contact information:

Mauricia Buchanan R.N., C.C.R.C.

(904)953-9455

Buchanan.Mauricia@mayo.edu