Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
- Conditions
- Abdominal Aortic Aneurysms
- Registration Number
- NCT00522535
- Lead Sponsor
- Lombard Medical
- Brief Summary
Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.
Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.
Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.
Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
- Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or
- Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.
- Less than 21 years of age,
- Life expectancy less than 2 years,
- Pregnant,
- Religious cultural or other objection to the receipt of blood or blood products,
- Unwilling to comply with follow-up schedule,
- Unwillingness or inability to provide informed consent to both trial and procedure.
- Patients not expected to live more than 2 years from enrollment
- Patient has a ruptured aneurysm
- Aneurysm extends above renal arteries
- Proximal neck of aneurysm has significant loose thrombus associated with it
- Patient with an acute or chronic aortic dissection or mycotic aneurysm
- Patient has current non-localized infection (may be recruited following remission of the infection)
- Patient is allergic to device materials
- Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl
- Patient is clinically and morbidly obese such that imaging would be severely adversely affected
- Patient has renal failure (serum creatinine > 2.5 mg/dL)
- Patient has an uncorrectable bleeding abnormality
- Patient has unstable angina
- Patient is receiving dialysis:
- Inflammatory aneurysm
- MI in last 6 months
- End stage COPD
- Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)
- Significant (>80%) renal artery stenosis which cannot be readily treated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Aorfix™ vs. Open Control All Cause Mortality 1 year The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.
- Secondary Outcome Measures
Name Time Method Aorfix™ vs. Open Control Adverse Events 30 days The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
Trial Locations
- Locations (38)
UAB Vascular Surgery
🇺🇸Birmingham, Alabama, United States
University of Arizona, Department of Surgery
🇺🇸Tucson, Arizona, United States
Long Beach VA Healthcare System
🇺🇸Long Beach, California, United States
UCSF Division of Vascular Surgery
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
🇺🇸Fort Lauderdale, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
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