Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Not Recruiting

Trial ID: NCT00522535

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

Stanford Investigator(s)

Ronald L. Dalman MD
Ronald L. Dalman MD

Dr. Walter C. Chidester Professor

Eligibility

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

Intervention(s):

device: Stent Graft

procedure: Open surgical repair

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee
6507255227