The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomiâ„¢ sirolimus eluting coronary stent system (Ultimaster Nagomiâ„¢) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Patient 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 site
✓. Ischemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedure
✓. Intention to treat all lesions requiring a PCI with the Ultimaster Nagomi stent
✓. Multivessel PCI defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts treated with a stent
✓. ≥ 3 stents implanted
✓. ≥ 3 lesions treated
✓. Complex 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:
Exclusion 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 guidelines
✕. Hypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicated
✕. Known contrast sensitivity that cannot be premedicated