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

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-30

Study Completion Date

2027-08-16

Brief Summary

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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).

Detailed Description

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A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Conditions

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Aortoiliac Occlusive Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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GORE VIABAHN® VBX Balloon Expandable Endoprosthesis

Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Intervention Type DEVICE

Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Interventions

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GORE 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.

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leigh Ann O'Banion, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Michele Antonello, M.D.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria di Padova

Locations

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University of California

Fresno, California, United States

Site Status RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Cooper University Hospital

Camden, New Jersey, United States

Site Status RECRUITING

Rutgers

New Brunswick, New Jersey, United States

Site Status RECRUITING

Research Foundation SUNY Buffalo

Buffalo, New York, United States

Site Status RECRUITING

Mount Sinai Medical Center

New York, New York, United States

Site Status RECRUITING

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Site Status RECRUITING

The University of Texas Austin

Austin, Texas, United States

Site Status RECRUITING

Carilion Clinic

Roanoke, Virginia, United States

Site Status RECRUITING

Marshfield Hospital

Marshfield, Wisconsin, United States

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Padova

Padua, , Italy

Site Status NOT_YET_RECRUITING

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status NOT_YET_RECRUITING

Amsterdam UMC Research BV

Amsterdam, , Netherlands

Site Status RECRUITING

Franciscus

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status RECRUITING

Greater Glasgow Health Board

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

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United States Italy Netherlands Spain United Kingdom

Central Contacts

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Jennifer Camoriano, BS

Role: CONTACT

14805365820

Chris Timberlake, BS

Role: CONTACT

1-928-707-4974

Facility Contacts

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Jessica Gallegos

Role: primary

Samantha Knight

Role: primary

Jonelle O'Shea

Role: primary

Marie Macor

Role: primary

Dawn Holler

Role: primary

Bridget Coyle

Role: primary

Subhashish Das

Role: primary

Carolina Reyes

Role: primary

Ashley Bowen

Role: primary

Andrea Stapper

Role: primary

Yili Zhong

Role: primary

Angela Varsho

Role: primary

Gabriele Piffaretti

Role: primary

Rutger Lely

Role: primary

Jerome van Brussel

Role: primary

Elisabeth Cruces Fuentes

Role: primary

Martin Hennessy

Role: primary

Other Identifiers

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VBX 24-03

Identifier Type: -

Identifier Source: org_study_id

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