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

NCT07855614 | Not Yet Recruiting

• 1 other identifier: ZJHIRB-2026-034K
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Target Vessel Failure (TVF) through 12 Months

  1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

• Peri-Procedural and In-Hospital Safety Events

  From PCI through hospital discharge or 30 days, whichever occurs first

• 12-Month Safety Outcomes

  1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

Study Arms (2)

Standard IVUS-Guided PCI

ACTIVE COMPARATOR

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

Imaging Fusion-Guided PCI

EXPERIMENTAL

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.

Device: AI-Based Imaging Fusion Guidance System; Procedure: Standard IVUS-Guided PCI

Interventions

AI-Based Imaging Fusion Guidance System DEVICE

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.

Imaging Fusion-Guided PCI

Standard IVUS-Guided PCI PROCEDURE

Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.

Imaging Fusion-Guided PCI; Standard IVUS-Guided PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Zhejiang Hospital: lead

Study Sites (8)

Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Location

First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Hangzhou First People's Hospital affiliated with Westlake University School of Medicine

Hangzhou, Zhejiang, China

Location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, China

Location

Yuhuan Second People's Hospital

Yuhuan, Zhejiang, China

Location

Zhoushan Hospital

Zhoushan, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Changqing Du

  Zhejiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changqing Du

CONTACT

+86-13656680012; ddcq82@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: PCI operators are unmasked; participants, the independent imaging core laboratory, the Clinical Events Committee, outcome assessors, and statisticians are masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, 1:1 parallel-group randomized superiority study stratified by study center.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)