Atheromatous coronary artery disease Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
Observational collection of routine hospital practice, clinical follow-up for monitoring of adverse and major cardiac events (death, infarction, re-interventions on target lesion, stent thrombosis), d
Sponsors
Terumo Europe N.V. (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is at least 18 years old, either sex 2. The patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and reference vessel diameter [RVD] matches available Nobori™ DES sizes) 3. Patient or the patient?s legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all patients complying with inclusion criteria. It is also desirable to have at least two cardiologists as investigators in each centre.
Exclusion criteria
Exclusion criteria: Exclusion criteria will be according to the instructions for the use of the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device oriented composite endpoint, defined as cardiac death, myocardial infarction (Q-wave and non-Q-wave not clearly attributable to non-target vessel) and clinically driven target lesion revascularisation at 12 months post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device oriented composite endpoint, defined as cardiac death, myocardial infarction (MI) (Q-wave and non-Q-wave not clearly attributable to non-target vessel) and clinically driven target lesion revascularisation at 1 and 6 months, 2, 3, 4 and 5 years post-procedure 2. Patient oriented composite endpoint defined as any cause mortality, MI (Q wave and non-Q wave), or any clinically driven target vessel revascularisation at 1, 6 and 12 months and at 2, 3, 4 and 5 years 3. Death and MI at 1, 6 and 12 months, 2, 3, 4 and 5 years 4. Death and post-procedural MI at 1, 6 and 12 months, 2, 3, 4 and 5 years 5. Stent thrombosis (definite and probable according to Academic Research Consortium [ARC] definitions) at 1, 6 and 12 months, 2, 3, 4 and 5 years 6. Primary stent thrombosis (definite and probable according to ARC definitions) at 1, 6 and 12 months, 2, 3, 4 and 5 years 7. Secondary stent thrombosis (definite and probable according to ARC definitions) at 1, 6 and 12 months, 2, 3, 4 and 5 years 8. Duration of dual antiplatelet therapy 9. Death, post-procedural MI and stent thrombosis rate during the course of dual antiplatelet therapy versus the same events after cessation of dual antiplatelet therapy 10. Clinically driven target lesion revascularisation (TLR) at 1, 6 and 12 months, 2, 3, 4 and 5 years 11. Clinically driven target vessel revascularisation (TVR) at 1, 6 and 12 months, 2, 3, 4 and 5 years 12. Total revascularisation rate (clinically and non clinically driven) at 1, 6 and 12 months, 2, 3, 4 and 5 years 13. Device success defined as the attainment of less than 30% residual stenosis by visual assessment using the Nobori™ stent only 14. Lesion success defined as the attainment of less than 30% residual stenosis by visual assessment using any percutaneous method 15. Procedure success defined as achievement of a final diameter stenosis of less than 30% by visual assessment using any percutaneous method, without the occurrence of death, Q wave or non-Q wave MI, | — |
Countries
Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Indonesia, Israel, Italy, Korea, South, Latvia, Macao, Malaysia, Morocco, Netherlands, New Zealand, Russian Federation, Serbia, Singapore, Slovenia, Sweden, Switzerland, Tunisia, Turkey, United Kingdom, Viet Nam
Outcome results
None listed