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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Changqing Du
- Telefonní číslo: +86-13656680012
- E-mail: ddcq82@126.com
Studijní místa
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Zhejiang
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Hangzhou, Zhejiang, Čína
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Čína
- Zhejiang Hospital
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Hangzhou, Zhejiang, Čína
- Affiliated Hospital of Hangzhou Normal University
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Hangzhou, Zhejiang, Čína
- First Affiliated Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Čína
- Hangzhou First People's Hospital affiliated with Westlake University School of Medicine
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Hangzhou, Zhejiang, Čína
- Second Affiliated Hospital, Zhejiang University School of Medicine
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Yuhuan, Zhejiang, Čína
- Yuhuan Second People's Hospital
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Zhoushan, Zhejiang, Čína
- Zhoushan Hospital
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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 Criteria:
- 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.
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Aktivní komparátor: 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. |
Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization. |
|
Experimentální: 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. |
Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization. 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. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Immediate Post-PCI Target-Vessel Composite Optimization Success
Časové okno: Immediately after PCI (0 hours, before leaving the catheterization laboratory)
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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)
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Target Vessel Failure (TVF) through 12 Months
Časové okno: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
|
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
|
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Peri-Procedural and In-Hospital Safety Events
Časové okno: From PCI through hospital discharge or 30 days, whichever occurs first
|
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
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12-Month Safety Outcomes
Časové okno: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
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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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Changqing Du, Zhejiang Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- ZJHIRB-2026-034K
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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