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

July 6, 2026 updated by: W.L.Gore & Associates
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Padova, Italy, 35131
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria di Padova
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale di Circolo e Fondazione Macchi
        • Contact:
          • Gabriele Piffaretti
        • Principal Investigator:
          • Gabriel Piffaretti, MD
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Recruiting
        • Amsterdam Umc Research Bv
        • Contact:
          • Rutger Lely
        • Principal Investigator:
          • Rutger Lely, MD
      • Rotterdam, Netherlands, 3045 PM
        • Recruiting
        • Franciscus
        • Contact:
          • Jerome van Brussel
        • Principal Investigator:
          • Jerome van Brussel, MD
  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
          • Elisabeth Cruces Fuentes
        • Principal Investigator:
          • Elisabeth Cruces Fuentes, MD
  • United Kingdom
      • Glasgow, United Kingdom, G12 OXH
        • Recruiting
        • Greater Glasgow Health Board
        • Contact:
          • Martin Hennessy
        • Principal Investigator:
          • Martin Hennessy, MD
  • United States
    • California
      • Fresno, California, United States, 93721
        • Recruiting
        • University of California
        • Contact:
          • Jessica Gallegos
        • Principal Investigator:
          • Leigh Ann O'Banion, MD
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • Samantha Knight
        • Principal Investigator:
          • Fahad Shuja, MBBS
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
          • Jonelle O'Shea
        • Principal Investigator:
          • Laurel Hastings, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers
        • Contact:
          • Marie Macor
        • Principal Investigator:
          • William Beckerman, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Research Foundation SUNY Buffalo
        • Principal Investigator:
          • Linda Harris, MD
        • Contact:
          • Dawn Holler
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Ajit Rao, MD
        • Contact:
          • Bridget Coyle
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Research Foundation at SUNY Syracuse
        • Principal Investigator:
          • Palma Shaw, MD
        • Contact:
          • Maria Walker
        • Sub-Investigator:
          • Fawaz Araim, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health Sanger Heart & Vascular Institute
        • Contact:
          • Houston Chapman
        • Principal Investigator:
          • Hector Crespo-Soto, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Medical Center
        • Contact:
          • Subhashish Das
        • Principal Investigator:
          • Kyongjune Lee, MD
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
          • Rebecca Mack
        • Principal Investigator:
          • Evan Ryer, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Grace WANG, MD
        • Contact:
          • Carolina Reyes
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Clinical Vascular Associates
        • Contact:
          • Karla Reily
        • Principal Investigator:
          • Anand Dayama, MD
    • Tennessee
      • Kingsport, Tennessee, United States, 37760
        • Recruiting
        • Wellmont Holston Valley Medical Center
        • Contact:
          • Ashley Bowen
        • Principal Investigator:
          • Ryan Cronin, MD
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Lori Michalowski
        • Principal Investigator:
          • Daniiel Clair, MD
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • The University of Texas Austin
        • Contact:
          • Andrea Stapper
        • Principal Investigator:
          • Meryl Logan, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
          • Robin Kelly
        • Principal Investigator:
          • Behzad Farivar, MD
      • Roanoke, Virginia, United States, 24016
        • Recruiting
        • Carilion Clinic
        • Contact:
          • Yili Zhong
        • Principal Investigator:
          • Esmaeel Dadashzadeh, MD
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Recruiting
        • Marshfield Medical Center - Marshfield
        • Contact:
          • Angela Varsho
        • Principal Investigator:
          • Shameem Kunhammed, MD
      • Marshfield, Wisconsin, United States, 54449
        • Recruiting
        • Marshfield Hospital
        • Contact:
          • Angela Varsho
        • Principal Investigator:
          • Shameem Kunhammed, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

The study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population.

Considering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia.

According to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis
Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
Time Frame: 1-Year
Proportion of patients maintaining primary patency at 1 Year
1-Year
Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
Time Frame: 30-Day
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
30-Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: At index procedure
Proportion of patients with technical success
At index procedure
Mortality
Time Frame: 30-Day
Proportion of patients with all cause death
30-Day
Device Integrity
Time Frame: 1 year
Proportion of patients achieving Primary Patency
1 year
Primary assisted patency
Time Frame: 1 year
Proportion of patients achieving Primary Assisted patency
1 year
Secondary patency
Time Frame: 1 year
Proportion of patients achieving Secondary Patency
1 year
Freedom from Target Lesion Revascularization
Time Frame: 1 year
Proportion of patients achieving freedom from Target Lesion Revascularization
1 year
Survival
Time Frame: 1 Year
Proportion of patients survival
1 Year
Freedom from Clinically-Driven Target Lesion Revascularization
Time Frame: 1 year
Proportion of patients achieving freedom from Clinically-Driven Target Revascularization
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Leigh Ann O'Banion, M.D., University of California, San Francisco
  • Principal Investigator: Michele Antonello, M.D., Azienda Ospedaliero-Universitaria di Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

August 16, 2027

Study Completion (Estimated)

August 16, 2027

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBX 24-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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