Peripheral Vascular Disease - SALVAGE

The SALVAGE Trial is a physician investigational device exemption (IDE) sponsored by VPI Physicians, Inc. This study is a prospective, multicenter evaluation of the safety and performance of the Spectranetics Laser with adjunct Percutaneous Transluminal Angioplasty (PTA) and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of patients with chronic lower limb ischemia associated with femoro-popliteal nitinol instent restenosis.

• A total of up to 100 subjects will be enrolled from up to 15 U.S. sites.
• All enrolled subjects will be tracked through 12 months to assess incidence of target lesion revascularization (TLR) and major adverse cardiac events (MACE).
• Follow-up visits occur at 30 days, 6 months, and 12 months.
• This study currently has FDA approval.