W.L.Gore & Associates
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.
Preoperative 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. Intraoperative Inclusion Criteria: * Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by i…
Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
Arctuva estimate
Actual pay is set by the research site.
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