Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 401
- Locations
- 1
- Primary Endpoint
- Freedom From Aneurysm Rupture
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Endovascular Aneurysm Repair
Investigational stent-graft implant to exclude aneurysm
Intervention: Endovascular Aneurysm Repair (Device)
Outcomes
Primary Outcomes
Freedom From Aneurysm Rupture
Time Frame: 2 years
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Secondary Outcomes
No secondary outcomes reported
Investigators
Federico Ezequiel Parodi
Staff
The Cleveland Clinic