Medtronic Concludes Enrollment in Clinical Study of Complete SE Vascular Stent
August 6, 2010—Medtronic, Inc. (Minneapolis, MN) announced that it has completed enrollment 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. The US Food and Drug Administration approved the study under an investigational device exemption.
According to Medtronic, the Complete SE SFA study is a prospective, multicenter, single-arm trial to evaluate the safety and efficacy of the Complete SE vascular stent system for treating de novo and/or restenotic lesions or occlusions in the SFA/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.
John Laird, MD, who served as the study’s United States principal investigator, commented to Endovascular Today, “This is an important prospective, multicenter, international registry that will give us additional information about the efficacy of nitinol stents in the SFA. One hundred ninety-six patients with lesions up to 15 cm in length in the SFA and proximal popliteal artery were treated with the Complete SE stent in this study, making this one of the largest cohorts of patients treated with SFA nitinol stents in any prospective registry. 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."