Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Detailed Description
-----------------
This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.

Official Title
-----------------
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Conditions
-----------------
Abdominal Aortic Aneurysm, Iliac Aneurysm, Internal Iliac Aneurysm

Intervention / Treatment
-----------------
* Device: Endovascular Aneurysm Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm Anticipated mortality greater than 10 percent with conventional surgery Life expectancy greater than 2 years Suitable arterial anatomy Absence of systemic disease or allergy that precludes an endovascular repair Capable of giving informed consent and willingness to comply with the follow-up schedule Exclusion Criteria: Pregnancy History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately Allergy to stainless steel or polyester Unwilling to comply with the follow-up schedule Serious or systemic groin infection Coagulopathy, other than coumadin therapy Inability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular Aneurysm Repair<br>Investigational stent-graft implant to exclude aneurysm | Device: Endovascular Aneurysm Repair<br>* Endovascular exclusion of aneurysm<br>* Other names: Cook Zenith;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Aneurysm Rupture | Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan | 2 years |