Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Not Recruiting

Trial ID: NCT00522535


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

Stanford Investigator(s)

Ronald L. Dalman MD
Ronald L. Dalman MD

Dr. Walter C. Chidester Professor


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

   - 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


device: Stent Graft

procedure: Open surgical repair

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee