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 · tracked via the Priya Life Science UK tracker

Sponsor

W.L.Gore & Associates

Phase

Observational

Started

2025-05-30

Last updated

2026-07-07

Condition(s) studied

Aortoiliac Occlusive Disease

Investigational drug(s) / intervention(s)

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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. \-

Primary outcome measure(s)

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

Trial sites (26)

Facility	City	Region	Status
University of California	Fresno	California	Recruiting
University of South Florida	Tampa	Florida	Recruiting
Mayo Clinic Rochester	Rochester	Minnesota	Recruiting
Cooper University Hospital	Camden	New Jersey	Recruiting
Rutgers	New Brunswick	New Jersey	Recruiting
Research Foundation SUNY Buffalo	Buffalo	New York	Recruiting
Mount Sinai Medical Center	New York	New York	Recruiting
Research Foundation at SUNY Syracuse	Syracuse	New York	Recruiting
Atrium Health Sanger Heart & Vascular Institute	Charlotte	North Carolina	Recruiting
Ohio State University Medical Center	Columbus	Ohio	Recruiting
Geisinger Medical Center	Danville	Pennsylvania	Recruiting
University Of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Sanford Clinical Vascular Associates	Sioux Falls	South Dakota	Recruiting
Wellmont Holston Valley Medical Center	Kingsport	Tennessee	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
The University of Texas Austin	Austin	Texas	Recruiting
University of Virginia	Charlottesville	Virginia	Recruiting
Carilion Clinic	Roanoke	Virginia	Recruiting
Marshfield Hospital	Marshfield	Wisconsin	Recruiting
Marshfield Medical Center - Marshfield	Marshfield	Wisconsin	Recruiting
Azienda Ospedaliero-Universitaria di Padova	Padova	Italy	Not Yet Recruiting
Ospedale di Circolo e Fondazione Macchi	Varese	Italy	Recruiting
Amsterdam UMC Research BV	Amsterdam	Netherlands	Recruiting
Franciscus	Rotterdam	Netherlands	Recruiting
Hospital General Universitario de Alicante	Alicante	Spain	Recruiting
Greater Glasgow Health Board	Glasgow	United Kingdom	Recruiting

More W.L.Gore & Associates trials in the UK

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease Recruiting

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis Recruiting

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance Recruiting

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis Active, not recruiting

Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application Active, not recruiting

Other trials for the same condition

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06872905 on ClinicalTrials.gov ↗ ← All trials in the UK