Coronary Artery DiseaseOPTIMAI-PCINCT07855614
OPTIMized Diagnosis and Treatment System Based on AI and Multimodal Imaging Fusion for PCI (OPTIMAI-PCI)
A study testing AI-Based Imaging Fusion Guidance System and Standard IVUS-Guided PCI in people with Coronary Artery Disease, run by Zhejiang Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- AI-Based Imaging Fusion Guidance System and Standard IVUS-Guided PCI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 8 sitesChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hangzhou First People's Hospital affiliated with Westlake University School of Medicine
Hangzhou, Zhejiang
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Hospital
Hangzhou, Zhejiang
Yuhuan Second People's Hospital
Yuhuan, Zhejiang
Zhoushan Hospital
Zhoushan, Zhejiang
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- AI-Based Imaging Fusion Guidance System, Standard IVUS-Guided PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Imaging Fusion Guidance SystemDevice
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.
Standard IVUS-Guided PCIProcedure or surgery
Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: AI-Based Imaging Fusion Guidance System; Procedure: Standard IVUS-Guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after PCI (0 hours, before leaving the catheterization laboratory)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, 1:1 parallel-group randomized superiority study stratified by study center.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changqing Du, Principal investigator, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855614
- Sponsor's protocol ID
- ZJHIRB-2026-034K
- Acronym
- OPTIMAI-PCI
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optimized Diagnosis and Treatment System Based on Artificial Intelligent and Multimodality Imaging Fusion for Percutaneous Coronary Intervention: a Prospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT07855614
- Acronym / sponsor ID
- OPTIMAI-PCI / ZJHIRB-2026-034K
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, 1:1 parallel-group randomized superiority study stratified by study center.
| Arm | Type | Receives |
|---|---|---|
| Standard IVUS-Guided PCI | Active comparator | Procedure: Standard IVUS-Guided PCIStandard percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural assessment, stent selection, and post-procedural optimization. |
| Imaging Fusion-Guided PCI | Experimental | Device: AI-Based Imaging Fusion Guidance System, Procedure: Standard IVUS-Guided PCIStandard 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Based Imaging Fusion Guidance SystemAI-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. | Device | Imaging Fusion-Guided PCI |
| Standard IVUS-Guided PCIPercutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization. | Procedure or surgery | Imaging Fusion-Guided PCI, Standard IVUS-Guided PCI |
Primary outcome
Immediate Post-PCI Target-Vessel Composite Optimization Success
Time frame: Immediately after PCI (0 hours, before leaving the catheterization laboratory)
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.
3 secondary outcomes
Target Vessel Failure (TVF) through 12 Months
Time frame: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
Peri-Procedural and In-Hospital Safety Events
Time frame: From PCI through hospital discharge or 30 days, whichever occurs first
12-Month Safety Outcomes
Time frame: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changqing Du principal investigator
Zhejiang Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Based Imaging Fusion Guidance System and Standard IVUS-Guided PCI in people with Coronary Artery Disease, run by Zhejiang Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changqing Du (+86-13656680012, ddcq82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Post-PCI Target-Vessel Composite Optimization Success (time frame: Immediately after PCI (0 hours, before leaving the catheterization laboratory)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.