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

Launched by W.L.GORE & ASSOCIATES · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medical device called the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, often referred to as the VBX Stent Graft. This device is used in a specific procedure called covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat a condition known as aortoiliac occlusive disease (AIOD), which affects blood flow in the arteries that lead to the legs. The goal of the study is to gather real-world data on how well this device works and how it is used in treating patients with this condition.

To be eligible for the trial, participants must be at least 18 years old and have undergone the CERAB procedure using the VBX Device at least one year before joining the study. They should not have had prior stenting in the aorta or common iliac artery during the same procedure, nor should they be involved in another clinical study that could interfere with the results. While the trial is not yet recruiting participants, those who qualify can expect to contribute valuable information that may help improve treatment options for others with similar health issues in the future.

Gender

ALL

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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