NAGOMI COMPLEX PMCF STUDY version 1.0

  • Research type

    Research Study

  • Full title

    A Post-Market Clinical Follow-up Study with Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Subjects

  • IRAS ID

    325214

  • Contact name

    Mamas Mamas

  • Contact email

    mamasmamas1@yahoo.co.uk

  • Sponsor organisation

    Terumo Europe N.V.

  • Clinicaltrials.gov Identifier

    NCT05705973

  • Clinicaltrials.gov Identifier

    T137E4, Study Protocol Reference Number

  • Duration of Study in the UK

    3 years, 6 months, 27 days

  • Research summary

    The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster NagomiTM sirolimus eluting coronary stent system (Ultimaster NagomiTM) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.
    The study is a prospective, multi-center, post-market clinical follow-up study. Subjects with an indication for a PCI according to current European Society of Cardiology (ESC) or national guidelines will be treated with the Ultimaster NagomiTM in accordance with the intended use. The PCI procedure will be per hospital routine practice including the option, as per physician preference, to assess the functional
    severity of the lesion, perform intra-coronary imaging, use lesion preparation devices or to perform a staged procedure. Also, post-procedural anti-platelet medication will be per ESC or national guidelines.
    The study will enrol 3,000 subjects from European sites. Follow-up will be 30days, 6month, 1year and 2 years, except for subjects in whom no Ultimaster NagomiTM stent was implanted and subjects that do not meet the inclusion criteria for a complex PCI as ascertained after the index procedure. These subjects will be followed until discharge.

  • REC name

    Wales REC 3

  • REC reference

    23/WA/0179

  • Date of REC Opinion

    14 Jun 2023

  • REC opinion

    Further Information Favourable Opinion