Multi Centre Study to Assess the Feasibility of a New Covered Stent and Delivery System in Combination with Remote Superficial Femoral Artery Endarterectomy (RSFAE)

Abstract

Objectives To evaluate the feasibility and efficacy of an innovative new covered stent and adjustable deployment system (aSpire™ Covered Stent, Vascular Architects Inc., San Jose, CA, USA) in combination with remote superficial femoral artery endarterectomy (RSFAE) for the treatment of long segment femoropopliteal occlusive disease. Design Prospective multi-centre trial. Materials and methods Sixty-two limbs in 61 patients (41 men; median age 69 years, range 40–88) with severe disabling claudication ( n=56) or critical limb ischaemia ( n=6) were treated in five European centres with aSpire stenting after RSFAE for long segment occlusions (mean length 25 cm). Follow-up was by duplex scanning at 1-, 6-, 12- and 18-months. Primary, primary-assisted and secondary patency rates were analysed. Results The median follow-up was 17 (range 2–34) months. A mean of 1.3 stents (range 1–3) were deployed with a median stent diameter of 7 mm (range 6–9). There were one early and 24 late failures. At 18-months the cumulative primary, primary-assisted and secondary patency rates were 60, 70 and 72%, respectively. There were no device related adverse events, such as kinking or fracturing and no stent migrations. Conclusions The aSpire stent and the delivery system are both safe and feasible in combination with RSFAE. The mid term follow-up appears favourable in view of the long segment occlusions treated. Further follow-up is required to compare the mid- and long-term outcomes with current stents and conventional femoropopliteal bypass.