<section id="hl0000325" class="abstract ng-scope"> <h2 id="hl0000326">Abstract</h2> <h2 id="hl0000328">Background</h2> <p id="hl0000329">The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.</p> <h2 id="hl0000331">Methods</h2> <p id="hl0000332">All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.</p> <h2 id="hl0000334">Results</h2> <p id="hl0000335">A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1).</p> <h2 id="hl0000337">Conclusion</h2> <p id="hl0000338">The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.</p> </section> <section id="hl0000339" class="abstract ng-scope"> <h2 id="hl0000340">Highlights</h2> <ul id="hl0000343" class="c-content-list"> <li id="hl0000344">aim of this registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB);</li> <li id="hl0000347">between July 2012 -September 2015 332 patients were enrolled at indian centres and clinically followed for 12 months post-procedure;</li> <li id="hl0000350">DOCE rate was 4.2% (n=14) which included death 0.3% (n=1), TLR 3.6% ( <em>n </em>=12) and myocardial infarction 0.3% (n=1);</li> <li id="hl0000354">the SCB showed to be safe and effective.</li> </ul> </section>