GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

Status Completed

Clinical Trial Summary

To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.

Clinical Trial Description

This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00228384
Study type	Interventional
Source	W.L.Gore & Associates
Contact
Status	Completed
Phase	Phase 4
Start date	September 2005
Completion date	January 2011

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