Gore and Spectranetics initiate enrollment in vascular trial

The physician-sponsored SALVAGE trial, is designed to evaluate the safety and performance of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface and the Spectranetics TURBO-Booster and TURBO elite laser catheter with the CVX-300 Excimer Laser System for the treatment of peripheral vascular disease (PVD) in the superficial femoral artery. Specifically, the study will evaluate the effectiveness of this combination therapy as a treatment for patients with chronic lower-limb ischemia associated with femoro-popliteal in-stent restenosis.

The SALVAGE trial will evaluate patients experiencing in-stent restenosis after being treated for PVD, also called Peripheral Arterial Disease (PAD). The SALVAGE Trial is a physician-sponsored investigational device exemption study by the Vascular Interventional Advances (VIVA) physicians that is co-funded by Gore and Spectranetics. This prospective, multi-center trial has a primary endpoint of 12-month patency measured by ultrasound. Up to 100 patients with in-stent restenosis of the SFA will be enrolled in the SALVAGE trial.

John Laird, principle investigator for the SALVAGE trial, said: “We expect that this landmark study will provide the medical community with critical insight into the possibilities of combining laser atherectomy and heparin-bonded stent grafts in the treatment of in-stent restenosis.”