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The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Not Recruiting
Trial ID: NCT01406795
Purpose
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.
Official Title
Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
Stanford Investigator(s)
Lawrence "Rusty" Hofmann, MD
Professor of Radiology (Interventional Radiology)
Gloria Hwang, MD
Clinical Professor, Radiology
David Hovsepian, MD
Clinical Professor, Radiology
John D. Louie, MD
Clinical Professor, Radiology
Daniel Sze, MD, PhD
Professor of Radiology (Interventional Radiology)
Stanley G. Rockson, MD
Allan and Tina Neill Professor of Lymphatic Research and Medicine
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
Professor of Radiology (Interventional Radiology)
Nishita Kothary, MD
Professor of Radiology (Interventional Radiology)
Eligibility
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
Intervention(s):
device: Gore Viabahn Heparin Coated Stent
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kamil Unver
650-725-9810