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pubmed-article:10825762pubmed:abstractTextThe purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm. Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5+/-10.8% to 2.7+/- 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [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 of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis 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 revascularization rates were low.lld:pubmed
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pubmed-article:10825762pubmed:articleTitleMulticenter registry to evaluate the efficacy of the NIROYAL stent in de novo or restenotic coronary stenosis.lld:pubmed
pubmed-article:10825762pubmed:affiliationVilla Maria Cecilia, Cardiology Department, Via Corriera 1, I-48010 Cotignola, Ravenna, Italy.lld:pubmed
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pubmed-article:10825762pubmed:publicationTypeResearch Support, Non-U.S. Gov'tlld:pubmed
pubmed-article:10825762pubmed:publicationTypeMulticenter Studylld:pubmed
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