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

NCT06872905 | Recruiting FDA Device

• 1 other identifier: VBX 24-03
• Study Type: observational
• Target: 158
• Locations: 5 countries
• Sites: 19

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).

Conditions

Aortoiliac Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)

  Proportion of patients maintaining primary patency at 1 Year

  1-Year

• Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)

  Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.

  30-Day

Secondary Outcomes (8)

• Technical Success

  At index procedure

• Mortality

  30-Day

• Device Integrity

  1 year

• Primary assisted patency

  1 year

• Secondary patency

  1 year

Study Arms (1)

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)

Interventions

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) DEVICE

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

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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) -

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (19)

University of California

Fresno, California, 93721, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Rutgers

New Brunswick, New Jersey, 08901, United States

RECRUITING

Research Foundation SUNY Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Mount Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37760, United States

RECRUITING

The University of Texas Austin

Austin, Texas, 78712, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24016, United States

RECRUITING

Marshfield Hospital

Marshfield, Wisconsin, 54449, United States

RECRUITING

Azienda Ospedaliero-Universitaria di Padova

Padua, 35131, Italy

NOT YET RECRUITING

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

NOT YET RECRUITING

Amsterdam UMC Research BV

Amsterdam, 1105, Netherlands

RECRUITING

Franciscus

Rotterdam, 3045 PM, Netherlands

NOT YET RECRUITING

Hospital General Universitario de Alicante

Alicante, 03010, Spain

RECRUITING

Greater Glasgow Health Board

Glasgow, G12 OXH, United Kingdom

RECRUITING

Study Officials

• Leigh Ann O'Banion, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Michele Antonello, M.D.

  Azienda Ospedaliero-Universitaria di Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Camoriano, BS

CONTACT

14805365820; jcamoria@wlgore.com

Chris Timberlake, BS

CONTACT

1-928-707-4974; ctimberl@wlgore.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 12, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): August 16, 2027
• Study Completion (Estimated): August 16, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (13); IT (2); NL (2); GB (1)