NCT06872905 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
| NCT ID | NCT06872905 |
| Status | Recruiting |
| Phase | — |
| Sponsor | W.L.Gore & Associates |
| Condition | Aortoiliac Occlusive Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 158 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2027-08-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 158 participants in total. It began in 2025-05-30 with a primary completion date of 2027-08-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. \-
Contact & Investigator
Leigh Ann O'Banion, M.D.
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06872905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Aortoiliac Occlusive Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06872905 currently recruiting?
Yes, NCT06872905 is actively recruiting participants. Contact the research team at jcamoria@wlgore.com for enrollment information.
Where is the NCT06872905 trial being conducted?
This trial is being conducted at Fresno, United States, Tampa, United States, Rochester, United States, Camden, United States and 11 additional locations.
Who is sponsoring the NCT06872905 clinical trial?
NCT06872905 is sponsored by W.L.Gore & Associates. The principal investigator is Leigh Ann O'Banion, M.D. at University of California, San Francisco. The trial plans to enroll 158 participants.