Medtronic announced on 6 August 2010 that it has completed 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.
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 the superficial femoral artery/proximal popliteal artery. The study enrolled 196 patients with symptomatic, ischemic peripheral arterial disease. The primary endpoints are major adverse events and patency of the stent at 12 months.
“Many people are unable to recognise the symptoms of peripheral arterial disease, and the condition is often undiagnosed by healthcare professionals,” said John Laird, medical director of the Vascular Center at the University of California, Davis, 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 peripheral arterial disease.”