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Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Trial ID or NCT#

NCT00522535

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

Ages Eligible for Study: Older than 21 Years

Sexes Eligible for Study: All

Accepts 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

View All Criteria

Investigator(s)

Jason T. Lee

Vascular surgeon

Professor of Surgery (Vascular Surgery) at the Stanford University Medical Center

Ronald L. Dalman MD

Vascular surgeon

Walter Clifford Chidester and Elsa Rooney Chidester Professor of Surgery

CONTACT

Jason Lee
(650) 725-5227

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View on ClinicalTrials.gov

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