Long-Term Results of the S.M.A.R.T. ControlTM Stent for Superficial Femoral Artery Lesions, J-SMART Registry

Background: The use of a stent in the treatment of lesions of the superficial femoral artery (SFA) remains controversial. Although some reports have suggested that use of a nitinol stent in conjunction with aggressive medical management is effective for long SFA lesions, few long-term, large-scale studies have been done. Methods and Results: A retrospective analysis was conducted of data from a multicenter study in which the S.M.A.R.T. ControlTM stent was used for treatment of de novo SFA lesions. A total of 528 lesions in 432 patients were included. Mean patient age was 72.5±9.1 years; mean stent length was 15.7±8.1cm; 259 lesions (49%) were classified as C/D according to the TransAtlantic Inter-Society Consensus (TASC) II classification. Primary and secondary patency at 4 years was 66% and 87%, respectively. No cilostazol administration (41% re-stenosis group vs. 29% no-restenosis group, P