The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).
A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.
Study Type
OBSERVATIONAL
Enrollment
158
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
University of California
Fresno, California, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGCooper University Hospital
Camden, New Jersey, United States
RECRUITINGRutgers
New Brunswick, New Jersey, United States
RECRUITINGResearch Foundation SUNY Buffalo
Buffalo, New York, United States
RECRUITINGMount Sinai Medical Center
New York, New York, United States
RECRUITINGOhio State University Medical Center
Columbus, Ohio, United States
RECRUITINGUniversity Of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGWellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
RECRUITINGThe University of Texas Austin
Austin, Texas, United States
RECRUITING...and 8 more locations
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
Proportion of patients maintaining primary patency at 1 Year
Time frame: 1-Year
Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
Time frame: 30-Day
Technical Success
Proportion of patients with technical success
Time frame: At index procedure
Mortality
Proportion of patients with all cause death
Time frame: 30-Day
Device Integrity
Proportion of patients achieving Primary Patency
Time frame: 1 year
Primary assisted patency
Proportion of patients achieving Primary Assisted patency
Time frame: 1 year
Secondary patency
Proportion of patients achieving Secondary Patency
Time frame: 1 year
Freedom from Target Lesion Revascularization
Proportion of patients achieving freedom from Target Lesion Revascularization
Time frame: 1 year
Survival
Proportion of patients survival
Time frame: 1 Year
Freedom from Clinically-Driven Target Lesion Revascularization
Proportion of patients achieving freedom from Clinically-Driven Target Revascularization
Time frame: 1 year
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