Sponsor : Terumo Europe

Brief summary

Nagomi Complex PMCF is a Post-Market Clinical Follow-up Study with Ultimaster Nagomi^TM 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.

Primary Endpoint

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.

CERC Services

CoreLab activities

Countries

Up to 60 sites in Europe