European Experience with the Self-Expanding Nitinol Coil: Pilot Phase Evaluation in Cardiovascular Applications

Background. The Cardiocoil (InStent) is a self-expanding nitinol coil that is restrained on a delivery catheter in a compressed state and deployed by a wire based release mechanism. We provide the initial data on the acute results of the use of this stent in a multi-center study in Europe. We also briefly review the other non-coronary applications of this stent. Methods. One hundred and two stents were implanted in 76 patients for suboptimal results or dissections. There were 39 LAD lesions, 28 RCA lesions and 9 Circumflex lesions. There were eight total occlusions. Lesions were short in 41% (<10mm), tubular (between 10 and 20 mm) in 37%, and diffuse (> 20%) in 22%. Stent deployment included predilatation to the reference arterial side and post dilatation after stent deployment. Results. Stent deployment were successful in all cases in which lesions could be crossed. In cases where the stent did not cross the lesion (n=3) it was removed uneventfully. There were no stent losses. Complications included subacute thrombosis in 4/76 (5.3%) patients (1- a long total RCA lesion, 2- diffuse proximal LAD diseases). There were no late acute events after stenting and no stent related mortality. Angiographie quantitative analysis showed that the stent expands by both its intrinsic self-expanding properties and by post deployment balloon assistance. Conclusions. The self-expanding coil stent for cardiovascular interventions is safe and effective in treating a variety of complex lesions. It provides adequate support to the arterial wall, preventing acute recoil and tacking dissections to the arterial wall. The long term efficiency of this stent awaits further clinical testine.