Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.

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