Initial Clinical Experience with the Protégé EverFlex™ Long Self-Expanding Nitinol Stent in the Superficial Femoral Artery

Aims: Clinical results following stent implantation in the superficial femoral artery (SFA) are limited due to restenosis, often caused by stent fractures. Therefore new stent devices are desirable. The present study details our initial experience with the routine use of the novel Protege EverFlex™ long self-expanding nitinol stent for treatment of long SFA total occlusions or stenoses. Methods and Results: Between February and March 2006 a total of 15 EverFlex™ nitinol stents were implanted in 12 patients with either total SFA occlusions (n = 9) or long stenoses (n = 3), mean lesion length 14.9 cm (± 10.4 cm). All patients presented with claudication stage Fontaine IIb (Rutherford category 3). Stent lengths were 10 cm (n = 6), 12 cm (n = 1), or 15 cm (n = 8), stent diameters were 6 mm (n = 14) and 7 mm (n = 1). Access was gained either by the crossover (n = 9), antegrade (n = 2), or popliteal approach (n = 1). After predilatation, stent placement and postdilatation were performed with 100% technical success. Clinical and apparative follow-up after 6–8 weeks indicated the absence of restenosis or reocclusion in all cases. Conclusion: The novel long self-expanding EverFlex™ nitinol stent (10 cm/12 cm/15 cm in length) exhibits excellent technical handling characteristics with good short-term clinical results. Mid-term and long-term clinical results as well as potential stent fractures need to be further examined.