RecruitingNCT06872905
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
Sponsor
W.L.Gore & Associates
Enrollment
158 participants
Start Date
May 30, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria5
- 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 ≥18 years at the time of CERAB procedure.
- Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
Exclusion Criteria4
- 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.
- \-
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Interventions
DEVICEGORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT06872905
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