The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Exclusion Criteria24

• 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):
• 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).
• Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.
• Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet 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 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.
• 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 can be managed, 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 or greater, acute Rutherford Type IIa or greater).
• Patient has a BMI \>45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic 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 anticoagulant medications on a long-term basis.
• Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).