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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Open surgical repair of abdominal aortic aneurysm
Endovascular repair of abdominal aortic aneurysm (EVAR)
UAB Vascular Surgery
Birmingham, Alabama, United States
University of Arizona, Department of Surgery
Tucson, Arizona, United States
Long Beach VA Healthcare System
Long Beach, California, United States
UCSF Division of Vascular Surgery
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Aorfix™ vs. Open Control All Cause Mortality
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.
Time frame: 1 year
Aorfix™ vs. Open Control Adverse Events
The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
Time frame: 30 days
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Harbor-UCLA Medical Center
Torrance, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
...and 28 more locations