This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
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 is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.
Single group
GORE® VIABAHN® FORTEGRA Venous Stent
DeviceTreatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
Primary effectiveness as assessed by primary patency
Rate of subjects with primary patency as confirmed by imaging and adverse events
Primary safety as assessed by SAEs
Rate of subjects with freedom from device- or index procedure-related SAEs
Rate of subjects with primary patency as confirmed by imaging and adverse events
Rate of subjects with freedom from both: * stent occlusion due to restenosis or thrombosis as confirmed with imaging, and * clinically driven target lesion revascularization as confirmed with imaging and adverse events
Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment
Freedom from permanent loss of blood flow through the device, regardless of reintervention
Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Rate of subjects with Repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the study devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of symptoms present at baseline, or the onset of new symptoms related to the target lesion
Number of subjects with stent embolization as confirmed by adverse events and imaging
Number of subjects with stent embolization
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