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NCT Number: 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

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).

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria di Padova, Padova, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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) -

Exclusion criteria

  • 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.

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Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1-Year

    Proportion of patients maintaining primary patency at 1 Year

  2. 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.

Secondary outcomes

  1. Technical Success

    Time frame: At index procedure

    Proportion of patients with technical success

  2. Mortality

    Time frame: 30-Day

    Proportion of patients with all cause death

  3. Device Integrity

    Time frame: 1 year

    Proportion of patients achieving Primary Patency

  4. Primary assisted patency

    Time frame: 1 year

    Proportion of patients achieving Primary Assisted patency

  5. Secondary patency

    Time frame: 1 year

    Proportion of patients achieving Secondary Patency

  6. Freedom from Target Lesion Revascularization

    Time frame: 1 year

    Proportion of patients achieving freedom from Target Lesion Revascularization

  7. Survival

    Time frame: 1 Year

    Proportion of patients survival

  8. Freedom from Clinically-Driven Target Lesion Revascularization

    Time frame: 1 year

    Proportion of patients achieving freedom from Clinically-Driven Target Revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Timberlake, BS

CONTACT

[email protected]

1-928-707-4974

Jennifer Camoriano, BS

CONTACT

[email protected]

14805365820

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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