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

Stanford University

Status

Terminated

Conditions

Venous Thrombosis

Treatments

Device: Gore Viabahn Heparin Coated Stent

Study type

Interventional

Funder types

Other

Identifiers

NCT01406795

IRB eProtocol - 14781

SU-01312011-7377

FDA IDE - G090054

SPO # 49275

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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