Multicenter registry to evaluate the efficacy of the NIROYAL (TM) stent inde novo or restenotic coronary stenosis

The purpose of this registry was to document the safety and efficacy of ele ctive deployment of the NIROYAL(TM) stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries, This was a prospective, multi-cente r international registry. NIROYAL(TM) stents (9, 16, 25 and 32 mm-long) wer e manually crimped onto coronary balloons and deployed in de novo or resten otic lesions in 165 male and female patients with angina pectoris and a ref erence vessel diameter of 2.0-4.5 mm, Stent deployment was successful in 98.8% of the lesions. Mean percent diame ter stenosis decreased from 83.5 +/- 10.8% to 2.7 +/- 6.2% after interventi on. The interventional procedure of the treatment site was successful in 97 .6% of patients. At sig-month clinical follow-up, 88.5% had event-free surv ival [i.e., did not experience a major adverse cardiac event (MACE)] and 95 .2% had no anginal symptoms. Furthermore, 87.3% of the patients were free o f target vessel failure (defined as a composite of acute procedural failure , target vessel revascularization, myocardial infarction or death at six mo nths). Only three MACE were observed within the first 30 days after stent i mplantation. A low left ventricular ejection fraction and the percentage st enosis pre-procedure were identified as statistically significant (p < 0.05 ) predictive factors for MACE, The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revasculariz ation rates were low.