The GORE® VIAFORT Vascular 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 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: uncorrected INR>2 (not as a result of warfarin or DOAC
therapy), OR platelet count <50,000 or >1,000,000 cells/mm3, OR 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 on
dialysis.

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

- Patient has known history of antiphospholipid syndrome (APS) or patients with
hypercoagulable states that are unwilling to take anticoagulant medications on a
long-term basis.

- Patient has known homozygous inherited coagulation defect or Protein C/S deficiency.

- Patient has a planned surgical intervention (other than pre-stenting procedures such
as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the
planned study procedure.

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

- Patient is currently participating in another investigational drug or device study
that has not completed the primary endpoint or that clinically interferes with the
endpoints 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 target
lower limb.

- Patient has known sensitivity to device materials or contraindication to
antiplatelets, thrombolytics, anticoagulants (including patients with known prior
instances of Heparin Induced Thrombocytopenia type 2 (HIT-2)), or iodinated contrast.

- 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 index
procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that is well
controlled under their current treatment regimen 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 or
greater, acute Rutherford Type IIa or greater).

- Patient has a BMI >40.

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

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 per
reference vessel diameter (see IFU), as determined by intraoperative IVUS post
pre-dilation.

- Patient must have appropriate access vessels to accommodate the delivery sheath for
the selected device size.

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

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

- Lesion can be traversed with a guidewire.

- Disease involves only unilateral iliofemoral venous segments with intent to stent all
affected iliofemoral segments. Patients with disease extending into the inferior vena
cava or contra-lateral iliofemoral veins who are anticipated to require endovascular
or surgical treatment within 12 months after investigational device implant will be
excluded.

- Patient does not have significant (i.e., >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.