This study compares an AI-based imaging fusion guidance system with standard intravascular ultrasound-guided PCI in adults with complex coronary artery lesions. The system combines angiography and intravascular ultrasound to help physicians plan and optimize stent placement. The study will assess whether the system improves immediate post-procedure vessel function and stent optimization without increasing safety risks.
Age 18 to 80 years, inclusive, at the time of informed consent.
Planned PCI for a target non-left-main coronary lesion meeting at least one of the following: typical myocardial ischemic symptoms with angiographic stenosis >70%; atypical symptoms with angiographic stenosis >=90%; functional measurement by FFR or QFR <0.80; or minimum lumen area below the protocol threshold for vessel diameter (<2.4 mm2 for <3.0 mm, <2.7 mm2 for 3.0-3.5 mm, or <3.6 mm2 for >3.5 mm).
Complex coronary lesion: a single diffuse long lesion >20 mm or tandem lesions separated by >10 mm of non-diseased vessel.
Participant or legally authorized representative can understand and sign written informed consent, can follow study procedures, and agrees to required contraception during the study.
Allergy or contraindication to heparin, aspirin, P2Y12 receptor antagonists, or contrast media, except contrast allergy controllable by premedication.
Active pathologic bleeding or gastrointestinal or genitourinary bleeding within 3 months before PCI.
Bleeding tendency or known coagulation disorder, including heparin-induced thrombocytopenia.
Life expectancy <1 year or inability to comply with the protocol, in the investigator's judgment.
Parallel
AI-Based Imaging Fusion Guidance System
DeviceAI-based software device for real-time fusion of coronary angiography and intravascular ultrasound during PCI. It supports virtual stent planning, stent recognition and reconstruction, quantitative evaluation of stent expansion and apposition, detection of edge complications, and functional assessment support including micro quantitative flow ratio.
Standard IVUS-Guided PCI
Procedure/SurgeryPercutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.
Immediate Post-PCI Target-Vessel Composite Optimization Success
Proportion of participants whose target vessel simultaneously meets all three core-laboratory-assessed criteria after final PCI optimization: post-PCI micro quantitative flow ratio (muQFR) \>=0.90; minimum stent area (MSA) \>=5.0 mm2; and no major stent-edge failure. Major edge failure is defined as longitudinal geographic mismatch (plaque burden \>=50% within 5 mm proximal or distal to the stent edge) and/or a major edge dissection involving the media and \>3 mm in length.
Target Vessel Failure (TVF) through 12 Months
Composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Suspected events will be adjudicated by the blinded Clinical Events Committee. Stent thrombosis will also be recorded.
Peri-Procedural and In-Hospital Safety Events
Incidence of bleeding events, contrast-associated adverse reactions, vascular access-site complications, peri-procedural myocardial infarction or acute vessel closure, serious adverse events, and other clinically significant adverse events during PCI and hospitalization.
12-Month Safety Outcomes
Incidence of serious adverse events, bleeding, stent thrombosis, stroke or systemic embolism, repeat hospitalization, and medication-related adverse reactions during follow-up.
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