Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
Gustavo S Oderich
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sched…
Interventions
- DeviceCustom-made Zenith® Fenestrated AAA Endovascular Graft:
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)
- Mayo ClinicRochester, Minnesota
- The University of Texas Health Science Center at HoustonHouston, Texas