The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

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.

Preoperative Inclusion Criteria: * 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. * Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent. * Estimated life expectancy ≥1 year. * Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable). * Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein. * Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction. Preoperative Exclusion Criteria: * 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. * Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for): 1. uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR 2. platelet count \1,000,000 cells/mm3, OR 3. white blood cell count \12,500 cells/mm3 * Patient has impaired renal function (eGFR \20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.