Ischemic heart disease perctaneous coronary intervention
Conditions
Interventions
Flow of PCI Procedures
The PCI procedures in this clinical trial shall follow the standardized steps described below.
The operator requirements for PCI in this study are defined as follows
The proced
Sponsors
Toba Takayoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients scheduled to undergo percutaneous coronary intervention (PCI) for complex coronary lesions. (2) Patients who are 18 years of age or older at the time of informed consent. (3) Patients who are able to understand the treatment and the purpose of the study, and who can provide written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Patients scheduled to undergo PCI for ostial lesions or chronic total occlusions . (2) Patients for whom continuation of antiplatelet therapy is not feasible (e.g., those scheduled to undergo surgery requiring discontinuation of antiplatelet agents within 1 month after PCI. (3) Patients who are pregnant, breastfeeding, or possibly pregnant. (4) Patients with a history of severe hypersensitivity to iodinated contrast media. (5) Patients lacking the capacity to provide informed consent due to dementia, impaired consciousness, delirium, severe psychiatric disorders, or intellectual disability. (6) Patients deemed unsuitable for study participation by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint Proportion of clear images (defined as cross-sectional vascular images with more than or equal to 270 degrees of the vessel lumen visualized) in both IVUS and OFDI images obtained by simultaneous IVUS and OFDI image acquisition after PCI. Assessment method) At 1 mm intervals across the target lesion and 5 mm proximal and distal reference segments, both IVUS and OFDI images will be individually evaluated. Safety Endpoint Adverse events attributable to the Dual Sensor System (DSS). Examples include coronary artery dissection, coronary spasm, coronary occlusion, intravascular thrombosis within the imaged vessel, difficulty in DSS catheter removal, and device malfunctions (e.g., failure of DSS operation resulting in inability to obtain images). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints Device success rate Utilization status of each imaging mode (IVUS alone, OFDI alone, and simultaneous IVUS and OFDI imaging) Quantitative and qualitative parameters obtained from the DSS PCI procedural success rate Safety Endpoints Periprocedural adverse events, including death, stroke, non-fatal myocardial infarction, vascular complications, and bleeding events | — |
Contacts
Public ContactTakayoshi Toba
Kobe University Hospital
Outcome results
None listed