Endovascular stent-grafts for superficial femoral artery disease: Results of 1-year follow-up

PURPOSE: To document a preliminary study to assess the deployment and outcomes of endoluminal stent grafting in the superficial femoral artery (SFA) with use of a prototype device. MATERIALS AND METHODS: Twenty patients with lifestyle-limiting intermittent claudication were selected for treatment with a balloon-mounted expansive polytetrafluoroethylene graft. All patients had ansographically proven SFA disease (median length, 17 cm) with normal arterial inflow and at least two calf vessels patent to the ankle, Follow-up was by means of ankle brachial pressure index (ABPI), duplex ultrasound, and angiography, RESULTS: Fourteen patients were successfully treated. Six patients were excluded: five by the study protocol and one because the procedure was a technical failure. ABPI rose from 0.6 before treatment to 1.0, The treated limbs became asymptomatic, Twelve-month primary, primary assisted, and secondary patency rates of treated patients were 29%, 50%, and 64%, CONCLUSION: Endovascular stent grafting of SFA lesions is technically feasible, but the patency rates obtained with this design are inferior to those obtained with conventional surgical bypass.