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 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% (< 10 mm), 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 was 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. Angiographic 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 testing.