Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Eligibility 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.
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Jason Lee
6507255227
View on ClinicalTrials.gov
