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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Houssam Farres, M.D.

Closed for enrollment

Contact information:

Mauricia Buchanan R.N.

(904)953-9455

Buchanan.Mauricia@mayo.edu

More information

Publications

  • This study was conducted to determine the costs and comparative cost-effectiveness of two methods of abdominal aortic aneurysm (AAA) repair in the Open Versus Endovascular Repair (OVER) Veterans Affairs (VA) Cooperative Study, a multicenter randomized trial of 881 patients. Read More on PubMed
  • For patients with large abdominal aortic aneurysms, randomized trials have shown an initial overall survival benefit for elective endovascular repair over conventional open repair. This survival difference, however, was no longer significant in the second year after the procedure. Information regarding the comparative outcome more than 2 years after surgery is important for clinical decision making. Read More on PubMed
  • To investigate whether endovascular aneurysm repair (EVAR) influences the rate of cardiovascular events (fatal or non-fatal myocardial infarction or stroke) in patients with abdominal aortic aneurysm (AAA) considered unfit for open repair. Read More on PubMed
  • Although the initial results of endovascular repair of abdominal aortic aneurysms were promising, current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair. Read More on PubMed
  • Endovascular aneurysm repair (EVAR) is a new technology to treat patients with abdominal aortic aneurysm (AAA) when the anatomy is suitable. Uncertainty exists about how endovascular repair compares with conventional open surgery. EVAR trial 1 was instigated to compare these treatments in patients judged fit for open AAA repair. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20348147

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