Lifespan Cardiovascular Institute Doctor Named Global Principal Investigator for Study Using Covered Stents for Unblocking Leg Arteries

April 10, 2015

Peter Soukas, MD, will manage 25 U.S. and foreign study sites during clinical trial

Metal_stentPeter A. Soukas, MD, director of vascular medicine at Rhode Island and The Miriam hospitals has been named as the global principal investigator of the Gore Viabahn covered stent for the treatment of femoropopliteal, bare-metal restenosis. The hospital will manage the multinational trial in 25 U.S. and European sites starting in June 2015.

Approved by the Food and Drug Administration (FDA) in 2009, the latest generation Gore Viabahn-covered endoprosthesis performed 47 percent better than balloon angioplasty alone in restenosis interventions during pre-approval clinical trials.

“This post-approval study will evaluate the performance of the stent in the treatment of lower extremity disease applications,” said Soukas, director of vascular medicine and the interventional vascular laboratories at The Miriam and Rhode Island hospitals, where he specializes in carotid stenting and the treatment of lower extremity disease.

“The new indication for the Gore Viabahn device provides physicians with a new means to extend the life of the intervention and improve patient outcomes,” he continued. “Here, the covered stent had a 75 percent primary patency versus 28 percent for the balloon angioplasty group, meaning it has greater success in treating restenosis of bare metal stents. Fewer repeat interventions benefit patient health immensely.”

The American Heart Association estimates that eight million Americans suffer from peripheral vascular disease (PVD). Untreated, PVD can lead to stroke or amputation.

The newly approved device is a flexible, metallic stent that is lined with a polytetrafluoroethylene (PTFE) coating. Soukas was a site investigator for the VIPER study (Viabahn endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease), which helped advance the approval of the technology by demonstrating its efficacy. This trial of 110 patients will begin this spring and end in 2015.

The trial is funded by W/L Gore. Soukas’ principal affiliation is The Miriam Hospital, and he also holds an academic appointment in the department of medicine at The Warren Alpert Medical School of Brown University, where he is the director of the vascular and endovascular medicine fellowship program. He has been actively involved in the evaluation of novel treatments for PVD and served as a site principal investigator for over 60 trials, including the Superb, Bioflex, VIPER and Open trials that evaluated novel stent designs for the femoropopliteal arterial segment.