NCT01406795

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

Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DEVICE	Gore Viabahn Heparin Coated Stent	For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-08-01
• Last updated: 2017-02-27
• Results posted: 2017-02-27

Locations

1 site across 1 country: United States