GORE VIABAHN VBX Post-Market Registry for Real-World Use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational registry designed to collect real-world data on patients treated with the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis. Enrolled participants may have de novo or restenotic iliac or visceral lesions, isolated aneurysms, or traumatic/iatrogenic vessel injuries, with follow-up through 12 months per standard of care. About 24 investigative sites in Europe will participate, with up to 240 subjects and a per-site cap of 48. Data collection will reflect routine clinical practice to inform post-market performance and safety of the device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. Informed Consent Form (ICF) is signed by subject
3. Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device
4. Willingness of the subject to adhere to institutional standard of care follow-up requirements

Exclusion Criteria:

1. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).
2. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
3. Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
4. Life expectancy \<12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
5. Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
6. Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.
7. Pregnant or breast-feeding subject at time of informed consent signature.
8. Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

Where it's running

• TUM Klinikum
  Munich, Germany Recruiting

Study contacts

• Principal investigator: Daniele Branzan, Prof. Dr. — TUM Klinikum
• Study coordinator: Cagla Selvan
• Email: cselvan@wlgore.com
• Phone: +31 627 294 665

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GORE MBA Arch Endoprosthesis Early Feasibility Study

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• GORE VIABAHN FORTEGRA Venous Stent Post-Approval Study

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• VIATORR TIPS 6–10 mm: Real-world use in cirrhosis with portal hypertension

  A real-world registry is seeing how the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 6-10 mm works over 2 years in adults with cirrhosis and portal hypertension.

  Recruiting at 5 sites W.L.Gore & Associates · Atlanta, Georgia and 4 other locations · NCT07390344

• GORE TBE Device in Zone 0/1 for Aortic Arch Conditions

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• TAMBE device post-marketing safety and effectiveness for thoracoabdominal and pararenal aortic aneurysms

  This tests whether the TAMBE multi-component device (GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis) is safe and works well for people treated for thoracoabdominal or pararenal aortic aneurysms in Japan.

  Recruiting at 5 sites W.L.Gore & Associates · Minatoku and 4 other locations · NCT07147569

• TBE stent-graft repair for thoracic aortic disease with Zone 2 proximal landing in Japan

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.