About this trial
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)
Eligibility criteria
Qualifiers
Age ≥18 years
Informed Consent Form (ICF) is signed by subject
Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device
Willingness of the subject to adhere to institutional standard of care follow-up requirements
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)