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
Sponsor organisation
Terumo Europe N.V.
Clinicaltrials.gov Identifier
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