Medtronic has announced the completion of enrolment in a clinical trial of the company’s Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA), including the proximal popliteal artery (PPA), which runs under the skin of the thigh.
Approved by the FDA under an investigational device exemption (IDE), the Complete SE SFA study is a prospective, multicentre, single-arm trial to evaluate the safety and efficacy of the Complete SE vascular stent system in the treatment of de novo and/or restenotic lesions or occlusions in both arteries.
The study enrolled 196 patients with symptomatic, ischemic peripheral arterial disease (PAD), with the two primary endpoints being major adverse events and patency of the stent at 12 months.
PAD of the lower extremities, including the SFA, affects approximately 8 million people in the United States each year, despite many patients being unaware of their condition or its consequences. PAD patients have a two to six-fold increase in cardiovascular mortality and develop a significantly increased risk of amputation, disability and diminished quality of life.
“Many people are unable to recognise the symptoms of PAD, and the condition is often undiagnosed by healthcare professionals,” said Dr John Laird, medical director of the Vascular Centre at the University of California, who served as the study’s US principal investigator. “With this trial, Medtronic is partnering with physicians around the world to expand clinical knowledge about a potentially serious health condition while at the same time generating data in support of the safety and efficacy of its Complete SE stent in the treatment of PAD.”