Purpose: 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.
Material and methods: 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.
Results: 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 technical success was achieved in 51/52 patients, with an optimal working channel after RA alone. Using Kaplan-Meyer analysis, primary vessel patency rates at 1, 6 and 12 -months was 96.1%, 86.5% and 76.9% respectively. Assisted primary patency at 1, 6- and 12 -months was 100%, 90.3% and 86.5% respectively.
Conclusions: Recanalisation with the Phoenix Atherectomy System is simple and safe, with a high technical success rate.
Keywords: Atherectomy; Atherosclerosis; Balloon angioplasty; Calcification; Femoropopliteal segment; Peripheral artery disease.
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