• A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry

    Abstract

    Background

    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.

    Methods

    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.

    Results

    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).

    Conclusion

    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.

    Highlights

    • aim of this registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB);
    • between July 2012 -September 2015 332 patients were enrolled at indian centres and clinically followed for 12 months post-procedure;
    • DOCE rate was 4.2% (n=14) which included death 0.3% (n=1), TLR 3.6% ( =12) and myocardial infarction 0.3% (n=1);
    • the SCB showed to be safe and effective.

    Author bio

    Cardiovascular Revascularization Medicine, Copyright © 2018 Elsevier Inc.

     

    Source:

    Read the full article on Science Direct: A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details