Nagomi Complex PMCF is a Post-Market Clinical Follow-up Study with Ultimaster NagomiTM Sirolimus Eluting Coronary Stent System in Complex PCI Subjects
3,000 Complex subjects eligible for a percutaneous coronary intervention are enrolled in the study.
Quantitative Coronary Angiography (QCA) will be performed for angiograms of the index procedure for a subset of 600 subjects with a bifurcation lesion.
Sponsor
Primary endpoints
The primary endpoint is Target Lesion Failure (TLF) defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization at 1-year post-procedure.
Secondary Endpoint(s):
Secondary endpoints will be evaluated post-procedure, at discharge, at 30 days, 6 months, 1 year and 2 years.
Delivery success
Procedure success
Lesion success
Device success
Target lesion failure (TLF)
Patient oriented composite endpoint (POCE)
All death and subclassifications
All myocardial infarction and subclassifications
All revascularization and subclassifications
All stent thrombosis and subclassifications
QCA of the index procedure angiogram for a subset of subjects with a Complex Bifurcation Lesion (CBL)
CERC Services
- CoreLab activities
Number of patients
Up to 60 sites in Europe
