Actively Recruiting
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
Led by W.L.Gore & Associates · Updated on 2026-03-30
158
Participants Needed
19
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
- Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
- Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
- Age 618 years at the time of CERAB procedure.
- Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC).
You will not qualify if you...
- Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
- Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
- Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of California
Fresno, California, United States, 93721
Actively Recruiting
2
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
5
Rutgers
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
6
Research Foundation SUNY Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
7
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
8
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
9
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37760
Actively Recruiting
11
The University of Texas Austin
Austin, Texas, United States, 78712
Actively Recruiting
12
Carilion Clinic
Roanoke, Virginia, United States, 24016
Actively Recruiting
13
Marshfield Hospital
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
14
Azienda Ospedaliero-Universitaria di Padova
Padova, Italy, 35131
Not Yet Recruiting
15
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Not Yet Recruiting
16
Amsterdam UMC Research BV
Amsterdam, Netherlands, 1105
Actively Recruiting
17
Franciscus
Rotterdam, Netherlands, 3045 PM
Not Yet Recruiting
18
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Actively Recruiting
19
Greater Glasgow Health Board
Glasgow, United Kingdom, G12 OXH
Actively Recruiting
Research Team
J
Jennifer Camoriano, BS
CONTACT
C
Chris Timberlake, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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