AI Imaging Guidance Versus Standard Ultrasound for Stent Placement in Coronary Artery Disease
Compares AI-assisted imaging with standard ultrasound guidance for stenting in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: OPTIMized Diagnosis and Treatment System Based on AI and Multimodal Imaging Fusion for PCI (OPTIMAI-PCI)
Key facts
- Where
- Hangzhou, Yuhuan, and Zhoushan, ChinaSee the 8 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who are planned for a stent procedure (PCI) for a long or tandem narrowing in a heart artery.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- A planned PCI on a heart artery narrowing (not the left main artery) that meets set criteria, such as stenosis >70% with typical chest symptoms, stenosis >=90% with atypical symptoms, FFR or QFR <0.80, or a small minimum lumen area. The narrowing must be one long lesion >20 mm or two lesions separated by >10 mm of healthy vessel.
- Earlier treatment
- No PCI on the same vessel within 12 months. No in-stent restenosis.
Main reasons for not taking part
- Left-main or bypass graft lesion
- Heart attack (STEMI) within 24 hours or cardiogenic shock
- Bleeding within 3 months, bleeding disorder, or allergy to blood thinners or contrast
- Severe liver, kidney, blood or mental illness, or dialysis
- Pregnant or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07855614, who can take part
Where in China
- Affiliated Hospital of Hangzhou Normal UniversityHangzhou, ChinaContact: Changqing DuNo longer taking part
- First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaContact: Changqing DuNo longer taking part
- Hangzhou First People's Hospital affiliated with Westlake University School of MedicineHangzhou, ChinaContact: Changqing DuNo longer taking part
- Second Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaContact: Changqing DuNo longer taking part
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Changqing DuNo longer taking part
- Zhejiang HospitalHangzhou, ChinaContact: Changqing DuNo longer taking part
- Yuhuan Second People's HospitalYuhuan, ChinaContact: Changqing DuNo longer taking part
- Zhoushan hospitalZhoushan, ChinaContact: Changqing DuNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhejiang Hospital
- Trial code
- NCT07855614
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
An Optimized Diagnosis and Treatment System Based on Artificial Intelligent and Multimodality Imaging Fusion for Percutaneous Coronary Intervention: a Prospective and Multicenter Study
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.
Inclusion: 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.
Exclusion: Active pathologic bleeding or gastrointestinal or genitourinary bleeding within 3 months before PCI; 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; 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; 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.