This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
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.
One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.
Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.
Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.
Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.
uncorrected INR>2 (not as a result of warfarin or DOAC therapy), OR
W.L.Gore & Associates
Lead sponsor