OPTIMized Diagnosis and Treatment System Based on AI and Multimodal Imaging Fusion for PCI (OPTIMAI-PCI)

Prior treatment

• Active pathologic bleeding or gastrointestinal or genitourinary bleeding within 3 months before PCI.

Other illness

• Allergy or contraindication to heparin, aspirin, P2Y12 receptor antagonists, or contrast media, except contrast allergy controllable by premedication.
• Bleeding tendency or known coagulation disorder, including heparin-induced thrombocytopenia.

Lab values

• Uncontrolled severe systemic disease, including severe hepatic, renal, hematologic, or psychiatric disease; examples include ALT or AST \>3 times the upper limit of normal, total bilirubin \>1.5 times the upper limit of normal, albumin \<35 g/L, cirrhosis or uncontrolled ascites, eGFR \<30 mL/min/1.73 m2 or dialysis, platelet count \<50 x 10\^9/L, hemoglobin \<80 g/L, hemolytic anemia, or aplastic anemia.

Other

• Life expectancy \<1 year or inability to comply with the protocol, in the investigator's judgment.
• Bypass graft lesion, left-main or unprotected left-main coronary lesion.
• STEMI within 24 hours of symptom onset or cardiogenic shock at admission (Killip class IV).
• Pregnant or breastfeeding participant, or plans for pregnancy or breastfeeding during the study.
• Target-vessel PCI within 12 months or in-stent restenosis.
• Severe calcified lesion or major epicardial coronary ostial lesion expected to require atherectomy pretreatment.
• IVUS catheter cannot cross the lesion.
• Angiographic image quality inadequate for muQFR analysis, including severe overlap, insufficient projections, or poor contrast filling.
  • Withdrawal and Exclusion from Per-Protocol Analysis:
• PCI not performed after randomization or key imaging missing and not recoverable; participant remains in the intention-to-treat set where applicable.
• Withdrawal of informed consent.
• Investigator judges continued participation may endanger the participant, such as a serious adverse event or very poor compliance.
  • Recruitment:
  • Participants will be screened among inpatients and outpatients scheduled for PCI for complex coronary lesions at participating centers. Investigators will explain the study and obtain written informed consent before enrollment.

• 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.