The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study

Inclusion Criteria

• •Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator/sub-investigator.
• •Patient is at least 18 years of age.
• •Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
• •Patient is able to provide informed consent themself.
• •Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
• •Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
• •Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.
• •Patient has adequate inflow/outflow to/from the target lesion(s), per investigator/sub- investigator discretion.
• •Lesion can be traversed with a guidewire.