Trial Search Results

The GORE Viabahn Endoprosthesis 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University


  • Device: Gore Viabahn Heparin Coated Stent




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

   - 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

   - Participating in another investigational study that has not completed follow-up

   - Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists

   - Absolute contraindication to contrast media or renal insufficiency (baseline
   creatinine >2.0 mg/dL).

   - Either a history or presence of heparin-induced thrombocytopenia antibodies

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kamil Unver