The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Stopped early · Not applicable
Conditions studied: Venous Thrombosis
In brief
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.
Key facts
- Study ID
- NCT01406795
- Run by
- Stanford University
- People needed
- 1
- Starts
- 2010-12-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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