Brief Title
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Official Title
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
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.
Study Type
Interventional
Primary Outcome
Aorfix™ vs. Open Control All Cause Mortality
Secondary Outcome
Aorfix™ vs. Open Control Adverse Events
Condition
Abdominal Aortic Aneurysms
Intervention
Open surgical repair
Study Arms / Comparison Groups
Open Surgical Repair
Description: Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
230
Start Date
April 2006
Completion Date
July 2020
Primary Completion Date
September 2011
Eligibility Criteria
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
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mark Fillinger, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00522535
Organization ID
PYTHAGORAS
Responsible Party
Sponsor
Study Sponsor
Lombard Medical
Study Sponsor
Mark Fillinger, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
Verification Date
October 2021