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To evaluate efficacy and safety of a new rotational atherectomy (RA), the Phoenix Atherectomy™ System, for the treatment of de novo and re-stenotic or occlusions atherosclerotic moderate-heavily lesions of the femoro-popliteal axis.

From January 2015 to August 2017, 52 patients with heavily calcified femoro-popliteal lesions causing severe stenosis or occlusions were enrolled in our center to be treated using Phoenix catheters. Primary endpoints of this study were acute efficacy and safety at 30 days. Secondary endpoints were freedom from restenosis and target lesion revascularization (TLR)/target vessel revascularization (TVR) at 1-, 6- and 12- months.

The mean lesion length was 9.2 cm (range 5-23 cm). The lesions were located in superficial femoral artery (SFA) in 61.5% (Fig. 1-A), in popliteal artery in 21.1% and involved femoral-popliteal axis in 15.4%. A primary …