heart disease
Conditions
Interventions
None listed
Sponsors
Terumo
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years 2) Subject 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 3) Ischemic heart disease with an indication for a PCI with, if available in the hospital, Heart Team consensus for a PCI procedure 4) Intention to treat all lesions requiring a PCI with the Ultimaster NagomiTM stent 5) Subject meets >= 1 of the complex procedure criteria: a) Multivessel PCI defined as >= 2 native coronary arteries and/or venous or arterial bypass grafts treated with a stent b) >= 3 stents implanted c) >= 3 lesions treated d) 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: 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, lithotripsy or cutting balloon
Exclusion criteria
Exclusion criteria: 1) 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 2) Hypersensitivity or contraindication to aspirin, heparin, L605 cobaltchromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicated 3) Known contrast sensitivity that cannot be premedicated 4) Pregnant and breastfeeding women 5) Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 • All strokes and subclassifications • All bleedings and subclassifications • Balance between bleeding (BARC 3-5) and thrombotic event (myocardial infarction and/or stent thrombosis) • Utilization of cardiovascular health care resources • Quality of Life (EQ-5D-5L) • Angina status (Seattle Angina Questionnaire, SAQ-7) • QCA of the index procedure angiogram for a subset of subjects with a Complex Bifurcation Lesion (CBL) | — |
Countries
Netherlands
Outcome results
None listed