Using the GORE VBX balloon-expandable stent graft for covered endovascular reconstruction of the aortic bifurcation in aortoiliac occlusive disease

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

This project will see if the GORE VBX balloon-expandable stent graft is safe and effective when used during covered endovascular reconstruction of the aortic bifurcation in adults treated for aortoiliac occlusive disease.

Quick facts

• Study type: Observational
• Enrollment: 158 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: W.L.Gore & Associates (industry)
• Locations: 19 sites (Fresno, California and 18 other locations)
• Trial ID: NCT06872905 on ClinicalTrials.gov

What this trial studies

This is a post-approval, observational collection of real-world data on the GORE VIABAHN VBX device when used in the CERAB technique to treat aortoiliac occlusive disease. At least 158 adult subjects treated at a minimum of 20 sites in the U.S. and Europe will be included, with retrospective data abstracted from site records. Data points include baseline, treatment, discharge, pre-12-month, 12-month, and later follow-up visits to capture safety and device performance over time. Patients must have undergone CERAB with the VBX device at least one year prior to enrollment and meet specific inclusion/exclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are adults who underwent a CERAB procedure with the VBX device placed in the aortic position at least one year earlier and who did not have prior aortic or common iliac stents or concomitant chimney procedures.

Not a fit: Patients with prior stents in the aortic or common iliac arteries, those treated with concomitant chimney procedures, or those enrolled in other conflicting investigational studies are excluded and unlikely to benefit from this data collection.

Why it matters

Potential benefit: If successful, this could provide real-world evidence to support safer and more effective use of the VBX device in CERAB procedures, helping clinicians optimize treatment for people with AIOD.

How similar studies have performed: Other observational and clinical reports have shown favorable outcomes with the VBX device and covered endovascular techniques for iliac disease, but CERAB-specific real-world data are relatively limited, making this focused collection somewhat novel.

Eligibility criteria

Inclusion Criteria:

1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
4. Age ≥18 years at the time of CERAB procedure.
5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -

Exclusion Criteria:

1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

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Where this trial is running

Fresno, California and 18 other locations

• University of California — Fresno, California, United States (RECRUITING)
• University of South Florida — Tampa, Florida, United States (RECRUITING)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (RECRUITING)
• Cooper University Hospital — Camden, New Jersey, United States (RECRUITING)
• Rutgers — New Brunswick, New Jersey, United States (RECRUITING)
• Research Foundation SUNY Buffalo — Buffalo, New York, United States (RECRUITING)
• Mount Sinai Medical Center — New York, New York, United States (RECRUITING)
• Ohio State University Medical Center — Columbus, Ohio, United States (RECRUITING)
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States (RECRUITING)
• The University of Texas Austin — Austin, Texas, United States (RECRUITING)
• Carilion Clinic — Roanoke, Virginia, United States (RECRUITING)
• Marshfield Hospital — Marshfield, Wisconsin, United States (RECRUITING)
• Azienda Ospedaliero-Universitaria di Padova — Padova, Italy (NOT_YET_RECRUITING)
• Ospedale di Circolo e Fondazione Macchi — Varese, Italy (NOT_YET_RECRUITING)
• Amsterdam UMC Research BV — Amsterdam, Netherlands (RECRUITING)
• Franciscus — Rotterdam, Netherlands (NOT_YET_RECRUITING)
• Hospital General Universitario de Alicante — Alicante, Spain (RECRUITING)
• Greater Glasgow Health Board — Glasgow, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Leigh Ann O'Banion, M.D. — University of California, San Francisco
• Study coordinator: Jennifer Camoriano, BS

Conditions: Aortoiliac Occlusive Disease