Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

28 de setembro de 2026 atualizado por: Zhejiang Hospital

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

554

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Changqing Du
  • Número de telefone: +86-13656680012
  • E-mail: ddcq82@126.com

Locais de estudo

    • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.

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.

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Immediate Post-PCI Target-Vessel Composite Optimization Success
Prazo: 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.

Immediately after PCI (0 hours, before leaving the catheterization laboratory)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Target Vessel Failure (TVF) through 12 Months
Prazo: 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
Peri-Procedural and In-Hospital Safety Events
Prazo: 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
12-Month Safety Outcomes
Prazo: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Changqing Du, Zhejiang Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de setembro de 2026

Primeira postagem (Real)

2 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever