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Not Recruiting
Trial ID: NCT01406795
Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
Professor of Radiology (Interventional Radiology)
Clinical Professor, Radiology
Clinical Professor, Radiology
Clinical Professor, Radiology
Professor of Radiology (Interventional Radiology)
Allan and Tina Neill Professor of Lymphatic Research and Medicine
Professor of Radiology (Interventional Radiology)
Professor of Radiology (Interventional Radiology)
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
device: Gore Viabahn Heparin Coated Stent
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kamil Unver
650-725-9810