Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/31/2017
Start Date:August 2013
End Date:December 2020
Contact:Jean R. Wigham, RN
Email:wigham.jean@mayo.edu
Phone:507-293-3496

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Gustavo S Oderich, MD
Phone: 507-293-3496
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials