Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts


About this study

This study will compare two groups of subjects with complex abdominal aortic aneurysms. It will compare their clinical outcomes and quality of life measures. The group being treated in this study will have their aneurysms repaired by an endovascular approach using Zenith® Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients (historical cohort) whose complex aneurysms were treated by open surgical repair.

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.

General Inclusion Criteria

A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:

  • Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
  • Aneurysm with a history of growth ≥ 0.5 cm per year.
  • Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.

General Exclusion Criteria

  • Less than 18 years of age
  • Unwilling to comply with the follow-up schedule
  • Inability or refusal to give informed consent by the patient or a legally authorized representative
  • Pregnant or breastfeeding
  • Life expectancy < 2-years
  • Additional medical restrictions as specified in the Clinical Investigation Plan
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

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

Rochester, Minn.

Mayo Clinic principal investigator

Bernardo Mendes, M.D.

Closed for enrollment

Contact information:

Jean Wigham R.N.


More information


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