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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• 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

Study contacts

• Principal investigator: Leigh Ann O'Banion, M.D. — University of California, San Francisco
• Study coordinator: Jennifer Camoriano, BS
• Email: jcamoria@wlgore.com
• Phone: 14805365820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.