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GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)

Recruitingn/aAges 18 Years - anyAllW.L.Gore & Associates
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In plain words

What the trial is, and whether it could suit you

Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
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Where

1 site
TUM Klinikum
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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