Status:
TERMINATED
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Lead Sponsor:
Stanford University
Conditions:
Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 diseas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01406795
Start Date
December 1 2010
End Date
December 1 2014
Last Update
February 27 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305