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
Gustavo S Oderich
200 participants
Aug 1, 2013
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria7
- 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
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Interventions
The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
Locations(2)
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NCT01937949