Chronic coronary syndrome
Conditions
Interventions
(1) SB (study treatment) group
DCB is performed after pre-dilation using a scoring balloon.
(2) Non-SB (conventional treatment) group
DCB is performed after pre-dilation using a conventional balloon.
Sponsors
Nakamura Daisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older at the time of consent 2) Patients who have received an explanation of the details of this study and whose written consent can be obtained 3) Patients who are deemed by the PCI operator to be eligible for DCB alone without the use of a stent 4) Patients who can receive dual antiplatelet therapy according to the latest guidelines after PCI 5) Patients who agree to follow-up CAG at 12 months after PCI.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating patients 2) Patients with in-stent restenosis lesions 3) Patients whose lesion is a graft lesion 4) Patients with acute coronary syndrome as the present culprit lesion 5) Patients with active bleeding complications 6) Patients who are currently participating in an interventional trial or who are participating or will participate in a clinical trial or a clinical study requiring intervention before the completion of the follow-up of this study 7) Patients expected to have a life expectancy of 1 year or less 8) Patients on maintenance hemodialysis 9) Patients with chronic total occlusion lesion 10) Patients allergic to paclitaxel and iopromide used in drug-eluting balloons 11) Patients with severe allergy to contrast media 12) Patients with cardiogenic shock 13) Other patients deemed inappropriate for this study by the principal investigator or subinvestigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of acquisition of both successful lesion preparation and late lumen enlargement (LLE) at 12 months after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of successful lesion preparation 2) Rate of bail-out DES implantation 3) Rate of LLE on OCT at 12 months after PCI 4) Late lumen loss on OCT at 12 months after PCI 5) QFR value at 12 months after PCI 6) Clinical outcomes: Major cardiac events (composite of cardiac death, acute myocardial infarction, target lesion revascularization, and device thrombosis), cardiac death, acute myocardial infarction, target lesion revascularization, target vessel revascularization, device thrombosis and bleeding complications at 12 and 36 months after PCI 7) Serial OCT findings at 1 month and 12 months after initial PCI 8) Serial NIRS-IVUS findings at 1 month and 12 months after initial PCI | — |
Contacts
Public ContactDaisuke Nakamura
The University of Osaka Hospital
Outcome results
None listed