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Clinical Trials in Spain / NCT06872905
Recruiting Observational

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 Spain 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
No
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)

FacilityCityRegionStatus
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 Spain

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis Active, not recruiting
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries Active, not recruiting
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry Active, not 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
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 Spain