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

Exclusion Criteria8

• 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).
• Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
• Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
• Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
• Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
• 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.
• Pregnant or breast-feeding subject at time of informed consent signature.
• Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).