The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses

Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses

To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. The use of the device for the treatment of peripheral arterial disease is approved by the FDA, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.

Inclusion Criteria:

• Patient is at least 18 years old
• Patient has clinical manifestations (i.e. symptoms and/or signs) of chronic DVT of an extremity. The Venous Clinical Severity Score (VCSS) will be used to determine if the patient is currently suffering from chronic DVT, with a VCSS score of 4 or greater necessary for inclusion.
• Imaging confirmation of venous occlusion or stenosis (>50%) involving the femoral, and/or popliteal veins
• Obstructed vessel caliber can accommodate a 7FR System, from insertion site to target segment
• Patient is able to read and answer a questionnaire in English

Exclusion Criteria:

• History of life-threatening reaction to contrast material
• Unwilling or unable to provide informed consent, or return for required follow-up evaluations
• Participating in another investigational study that has not completed follow-up testing
• Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists (VKAs)
• Absolute contraindication to contrast media or renal insufficiency (baseline creatinine >2.0 mg/dL).
• Either a history or presence of heparin-induced thrombocytopenia antibodies