Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.

General Inclusion Criteria:Age ≥ 18 yearsPatient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical siteIschemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedureIntention to treat all lesions requiring a PCI with the Ultimaster Nagomi stentComplex Procedure Inclusion CriteriaSubject meets ≥ 1 of the complex procedure criteria:Multivessel disease defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts with a lesion requiring PCI≥ 3 stents implanted≥ 3 lesions treatedComplex bifurcation lesion defined as true bifurcation lesion (Medina 1.1.1, 1.0.1 or 0.1.1) with a side branch diameter > 2.5 mm plus one of the following:i) side branch disease > 10 mm ii) calcified lesion iii) thrombotic lesion e) Bifurcation lesion implanted with two stents f) Total stent length implanted > 60 mm g) Chronic total occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least a 3-month duration h) Left main stenting (main stem and/or bifurcation) i) Instent restenosis j) Severe calcified lesion with use of atherectomy or lithotripsyExclusion Criteria:Any surgery requiring general anaesthesia, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelinesAn acute or evolving STEMI < 72 h after symptom onsetHypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicatedKnown contrast sensitivity that cannot be premedicatedPregnant and breastfeeding womenLife expectancy < 1 year for any cardiac or non-cardiac causeParticipation in another clinical study that has not yet completed its primary endpointEarlier enrolment in the Nagomi Complex studyUnlikely to be available for follow-up during the duration of the study (2 years)