Abdominal Aortic Aneurysms
Conditions
Keywords
AAA, Abdominal Aortic Aneurysms, Endovascular, EVAR, Aorta, Stent Graft, Stent, Tortuous, High Angle, Angled Necks
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.
Interventions
PROCEDUREOpen surgical repair
Open surgical repair of abdominal aortic aneurysm
DEVICEStent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Sponsors
Lombard Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed