nagomi complex PMCF
Sponsor : Terumo Europe
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.
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.
Up to 60 sites in Europe