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

Trial ID or NCT#

NCT01406795

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Lawrence "Rusty" Hofmann, MD
Lawrence "Rusty" Hofmann, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Gloria Hwang, MD
Gloria Hwang, MD
Interventional radiologist
Clinical Professor, Radiology
David Hovsepian, MD
David Hovsepian, MD
Interventional radiologist, Radiologist
Clinical Professor, Radiology
John D. Louie, MD
Interventional radiologist
Clinical Professor, Radiology
Daniel Sze, MD, PhD
Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Stanley G. Rockson, MD
Stanley G. Rockson, MD
Cardiologist
Allan and Tina Neill Professor of Lymphatic Research and Medicine
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Nishita Kothary, MD
Nishita Kothary, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)

Contact us to find out if this trial is right for you.

Contact

Kamil Unver
650-725-9810

View on ClinicalTrials.gov