The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

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 anyrequired medication or compression regimen.

• Patient is able to provide informed consent.

• One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSSpain 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 isacceptable).

• Patient has adequate inflow to the target lesion(s), perinvestigator/sub-investigator discretion, involving at least a patent femoral ordeep 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 butless than or equal to 90 days prior to treatment.

• Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnantthrough the 12-month visit.

• Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis,dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed TomographyAngiography) at the time of enrollment.

• Patient has a known uncorrectable bleeding diathesis or active coagulopathy meetingthe following definitions (all must be tested for):

1. uncorrected INR>2 (not as a result of warfarin or DOAC therapy), OR

2. platelet count <50,000 or >1,000,000 cells/mm3, OR

3. white blood cell count <3,000 or >12,500 cells/mm3

• Patient has impaired renal function (eGFR <30 mL/min/1.73m2) or is currently ondialysis.

• Patient has uncorrected hemoglobin of <9 g/dL.

• Patient has known history of antiphospholipid syndrome (APS).

• Patient has known homozygous or acquired coagulation defect (e.g., Protein C orProtein S deficiency) that cannot be treated with therapeutic anticoagulation.

• Patient has a planned surgical intervention that has the potential to clinicallyinterfere with the endpoints of this treatment (other than pre-stenting proceduressuch as thrombolysis or thrombectomy) within 30 days prior to or within 30 daysafter the planned study procedure. Examples include surgical interventions that mayimpact mobility, and surgical interventions that require cessation of therapeuticantiplatelet or anticoagulation within 30 days following the index procedure.

• Patient has had or requires open deep venous surgery in the target limb.

• Patient is currently participating in another investigational drug or device studythat has not completed the primary endpoint or that clinically interferes with theendpoints of this treatment, in the opinion of the investigator/sub-investigator.Observational studies are permitted.

• Patient has had a previous major (i.e., above the ankle) amputation of the targetlower limb.

• Patient has known sensitivity to device materials.

• Patient has had prior stenting or grafts in the target vessels.

• Patient has a known or suspected active systemic infection at the time of the indexprocedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that can bemanaged, and with an active clinical plan in place may be eligible.

• Patient has known history of intravenous drug abuse within one year of treatment.

• Patient has significant peripheral arterial disease (chronic Rutherford Type 2 orgreater, acute Rutherford Type IIa or greater).

• Patient has a BMI >45. Patients with a BMI of up to 45 may be enrolled provided thatdiagnostic quality ultrasound of the implant sites can be performed.

• Patient is actively undergoing or plans to begin cancer treatment.

• Patients with hypercoagulable states that are unwilling to take anticoagulantmedications on a long-term basis.

• Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrastnecessary for the index procedure and long-term medical therapy (contrastpre-medication is acceptable).

Intraoperative Inclusion Criteria:

• Presence of non-malignant unilateral obstruction of the common femoral vein,external iliac vein, and/or common iliac vein defined as occlusion or at least 50%reduction in target vessel lumen as measured by procedural IVUS and venogram.

• Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as perreference vessel diameter (see IFU), as determined by intraoperative IVUS postpre-dilation.

• Patient must have appropriate access vessels to accommodate the delivery sheath forthe selected device size.

• Patient has adequate landing zones free from significant disease requiring treatmentwithin the native vessels beyond the proximal and distal margins of the lesion.

• Patient has adequate inflow to the target lesion(s), perinvestigator/sub-investigator discretion, involving at least a patent femoral ordeep femoral vein.

• Lesion can be traversed with a guidewire.

• Disease involves only unilateral iliofemoral venous segments with intent to stentall affected iliofemoral segments. Patients with disease extending into the inferiorvena cava or contra-lateral iliofemoral veins who are anticipated to requireendovascular or surgical treatment within 12 months after investigational deviceimplant will be excluded.

• Patient does not have significant (i.e., >20% residual thrombosis) acute thrombuswithin the target stent area at the time of investigational device placement.Patients with acute thrombus within the target stent area must have thrombussuccessfully treated prior to investigational device placement. Successful thrombustreatment is defined as reestablishment of antegrade flow with ≤20% residualthrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascularinjury, or hemodynamically significant pulmonary embolism. After successful thrombustreatment, investigational device placement can occur within the same procedure.