Multicenter registry to evaluate the efficacy of the NIROYAL™ stent in de novo or restenotic coronary stenosis

Alberto Cremonesi, Edouardo Benit, Marc Carlier, Antonio Colombo, Roberto Piva, Peter Probst, Alexander Wirtzfeld, Claude Pico-Bourdonnec, Thierry Corcos

Research output: Contribution to journalArticlepeer-review


The 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.

Original languageEnglish
Pages (from-to)225-232
Number of pages8
JournalJournal of Invasive Cardiology
Issue number5
Publication statusPublished - May 2000


  • Coronary artery
  • Gold
  • Major adverse cardiac event
  • Stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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