coronary calcified nodule
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with calcified nodules in the culprit lesion detected by OCT or OFDI 2) Patients treated with DES or DCB 3) Patients over 20 years old 4) Patients with their own consent
Exclusion criteria
Exclusion criteria: 1) patients with life expectancy < 1 year 2) patients with shock status 3) patients with in-stent restenosis or stent thrombosis 4) patients with pregnancy 5) Patients deemed inappropriate for inclusion by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-oriented Composite Endpoint (PoCE) at 12 months after PCI: composite endpoint of all cause death, myocardial infarction and any revascularization Target lesion failure (TLF) at 12 months after PCI: composite endpoint of cardiac death, target vessel-related MI and clinically driven target lesion revascularization (TLR) | — |
Secondary
| Measure | Time frame |
|---|---|
| At 12 months after PCI 1) The components of primary outcomes 2) Stent thrombosis 3) Stroke 4) Bleeding event 5) Time to occurrence of each of the primary outcomes At 24 months after PCI 6) The composite endpoint of PoCE 7) The composite endpoint of TLF 8) The components of primary outcomes 9) Stent thrombosis 10) Stroke 11) Bleeding event 12) repeated TLR 13) Time to occurrence of each of the primary outcomes | — |
Countries
Japan
Contacts
Kobe University Graduate School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine