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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Standard IVUS-Guided PCI; Device: AI-Based Imaging Fusion Guidance System

Detailed Description

This prospective, multicenter, randomized, controlled superiority study will enroll adults undergoing PCI for complex non-left-main coronary artery lesions. Participants will be randomized 1:1, stratified by study center, to standard IVUS-guided PCI or PCI assisted by an AI-based imaging fusion guidance system. Both groups will receive standard PCI and peri-procedural care. The primary composite outcome is immediate target-vessel optimization after PCI, defined by post-PCI micro quantitative flow ratio of at least 0.90, minimum stent area of at least 5.0 mm2, and no major stent-edge failure. Clinical follow-up will occur at 1, 6, and 12 months to assess target-vessel failure and safety events.

• Study Type: Interventional
• Enrollment (Estimated): 554
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Changqing Du; Phone Number: +86-13656680012; Email: ddcq82@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China
      • Affiliated Hospital of Hangzhou Normal University
    • Hangzhou, Zhejiang, China
      • First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital affiliated with Westlake University School of Medicine
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital, Zhejiang University School of Medicine
    • Yuhuan, Zhejiang, China
      • Yuhuan Second People's Hospital
    • Zhoushan, Zhejiang, China
      • Zhoushan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 to 80 years, inclusive, at the time of informed consent.
2. 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).
3. Complex coronary lesion: a single diffuse long lesion >20 mm or tandem lesions separated by >10 mm of non-diseased vessel.
4. 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 Criteria:

1. Allergy or contraindication to heparin, aspirin, P2Y12 receptor antagonists, or contrast media, except contrast allergy controllable by premedication.
2. Active pathologic bleeding or gastrointestinal or genitourinary bleeding within 3 months before PCI.
3. Bleeding tendency or known coagulation disorder, including heparin-induced thrombocytopenia.
4. Life expectancy <1 year or inability to comply with the protocol, in the investigator's judgment.
5. Bypass graft lesion, left-main or unprotected left-main coronary lesion.
6. STEMI within 24 hours of symptom onset or cardiogenic shock at admission (Killip class IV).
7. 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.
8. Pregnant or breastfeeding participant, or plans for pregnancy or breastfeeding during the study.
9. Target-vessel PCI within 12 months or in-stent restenosis.
10. Severe calcified lesion or major epicardial coronary ostial lesion expected to require atherectomy pretreatment.
11. IVUS catheter cannot cross the lesion.
12. Angiographic image quality inadequate for muQFR analysis, including severe overlap, insufficient projections, or poor contrast filling.

Withdrawal and Exclusion from Per-Protocol Analysis:

1. PCI not performed after randomization or key imaging missing and not recoverable; participant remains in the intention-to-treat set where applicable.
2. Withdrawal of informed consent.
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard IVUS-Guided PCI; Standard percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural assessment, stent selection, and post-procedural optimization.	Procedure: Standard IVUS-Guided PCI; Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.
Experimental: Imaging Fusion-Guided PCI; Standard percutaneous coronary intervention with use of the AI-based imaging fusion guidance system for ICA-IVUS fusion, virtual stent planning, stent recognition and reconstruction, quantitative assessment of expansion and apposition, and edge-complication alerts.	Procedure: Standard IVUS-Guided PCI; Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.; Device: AI-Based Imaging Fusion Guidance System; AI-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after PCI (0 hours, before leaving the catheterization laboratory)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
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.	From PCI through hospital discharge or 30 days, whichever occurs first
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.	1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

Collaborators and Investigators

• Sponsor: Zhejiang Hospital
• Investigators: Principal Investigator: Changqing Du, Zhejiang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 28, 2026
• First Submitted That Met QC Criteria: September 28, 2026
• First Posted (Actual): October 2, 2026

Study Record Updates

• Last Update Posted (Actual): October 2, 2026
• Last Update Submitted That Met QC Criteria: September 28, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: ZJHIRB-2026-034K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be shared because the data include sensitive personal health information, and the currently approved informed consent and ethics documents do not authorize external sharing of participant-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No