This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Alexander Vezeridis, MD, PhD

Intervention(s):

device: GORE® VIAFORT Vascular Stent

Eligibility

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.

Preoperative Exclusion Criteria:

• Patient is a pregnant or breastfeeding woman, a woman planning to become pregnant through the 12-month visit, or a woman who is unwilling to practice an acceptable method of preventing pregnancy 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 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.

Ages Eligible for Study

18 Years and older

Genders Eligible for Study

All