IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT07329699 (AIM-FFR) para Doença arterial coronariana, Síndrome coronariana crônica, Síndrome coronariana aguda está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa
Samsung Medical CenterArtificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial) 2.100 Randomizado Multicêntrico Estudo aberto
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07329699 (AIM-FFR) é um estudo intervencionista para Doença arterial coronariana, Síndrome coronariana crônica, Síndrome coronariana aguda. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de março de 2026, com o objetivo de incluir 2.100 participantes. Coordenado por Samsung Medical Center e deve ser concluído em 31 de dezembro de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 12 de fevereiro de 2026.
Resumo
The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.
Descrição detalhada
Fractional Flow Reserve (FFR) has been established as the gold standard for determining the functional significance of coronary artery stenosis. Current guidelines have classified FFR as a Class IA recommendation for the assessment of intermediate coronary artery lesions. However, FFR remains underused in daily clinical practice, due to requirement for pressure wire use, hyperemia induction, or prolonged procedural t...Mostrar mais
Título oficial
Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI
Condições médicas
Doença arterial coronarianaSíndrome coronariana crônicaSíndrome coronariana agudaOutros IDs do estudo
- AIM-FFR
- SMC19810222
Número NCT
Data de início (real)
2026-03-01
Última atualização postada
2026-02-12
Data de conclusão (estimada)
2029-12-31
Inscrição (estimada)
2.100
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Coronary artery stenosis
Fractional flow reserve
Prognosis
Fractional flow reserve
Prognosis
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalMPFFR-guided PCI group In patients randomized to artificial intelligence-driven angiography-based fractional flow reserve (MPFFR)-guided PCI group, MPFFR analysis will be performed using MPFFR-1000 version 2.1.0 (Medipixel Inc., Seoul, Korea). Manual correction can be applied when necessary, however, it will be strongly discouraged by the study protocols. Treatment decisions will be made based on site-measured MPFFR value.
Functionally si...Mostrar mais | MPFFR or Invasive FFR Functionally significant stenosis will be defined as MPFFR≤0.80 or FFR≤0.80. For lesions with MPFFR≤0.80 or FFR≤0.80, PCI will be recommended under current guidelines, however, final decision regarding PCI will be at the discretion of operators. In the MPFFR-guided PCI group, on-site MPFFR value will be used in decision making of revascularization. If PCI is not performed for lesions with MPFFR≤0.80 or FFR≤0.80, the ...Mostrar mais |
Comparador ativoInvasive FFR-guided PCI group All invasive FFR measurements will be performed after diagnostic coronary angiography according to a standardized protocol as previously described. A pressure-temperature sensor guide wire (Abbott Vascular, Santa Clara, CA, USA) is positioned at the distal segment of the target lesion. To induce maximal hyperemia state, intravenous infusion of adenosine (140μg/kg/min through a peripheral vein) or intracoronary inject...Mostrar mais | MPFFR or Invasive FFR Functionally significant stenosis will be defined as MPFFR≤0.80 or FFR≤0.80. For lesions with MPFFR≤0.80 or FFR≤0.80, PCI will be recommended under current guidelines, however, final decision regarding PCI will be at the discretion of operators. In the MPFFR-guided PCI group, on-site MPFFR value will be used in decision making of revascularization. If PCI is not performed for lesions with MPFFR≤0.80 or FFR≤0.80, the ...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Major adverse cardiac events (MACE) | a composite of death from any causes, non-fatal myocardial infarction \[MI\], and clinically indicated unplanned revascularization | 1 year after last patient enrollment |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
All-cause death | All-cause death (defined by Academic Research Consortium \[ARC\] II definition) | 1 year after last patient enrollment |
Cardiovascular death | Cardiovascular death (defined by Academic Research Consortium \[ARC\] II definition) | 1 year after last patient enrollment |
Non-fatal myocardial infarction (MI) | Non-fatal MI (according to the Fourth universal definition of MI) | 1 year after last patient enrollment |
Target vessel-related MI | Target vessel-related MI (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR) | 1 year after last patient enrollment |
Non-target vessel-related MI | Non-target vessel-related MI (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR) | 1 year after last patient enrollment |
Clinically indicated unplanned revascularization | Clinically indicated unplanned revascularization (defined by Academic Research Consortium \[ARC\] II definition) | 1 year after last patient enrollment |
Clinically indicated target vessel revascularization | Clinically indicated target vessel revascularization (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR) | 1 year after last patient enrollment |
Clinically indicated non-target vessel repeat revascularization | Clinically indicated non-target vessel repeat revascularization (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR) | 1 year after last patient enrollment |
Vessel or Stent thrombosis | Vessel or Stent thrombosis (definite thrombosis defined by Academic Research Consortium \[ARC\] II definition) | 1 year after last patient enrollment |
Cardiovascular death or target vessel-related MI | A composite of Cardiovascular death or target vessel-related MI | 1 year after last patient enrollment |
Target vessel failure | Target vessel failure (TVF, a composite of cardiovascular death, target vessel-related MI, and clinically indicated target vessel revascularization) | 1 year after last patient enrollment |
Bleeding according to BARC definition | Bleeding according to BARC definition | 1 year after last patient enrollment |
Cerebrovascular accident (CVA) | Cerebrovascular accident (CVA) including ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) | 1 year after last patient enrollment |
Contrast volume (including both diagnostic angiography and PCI) | Contrast volume (including both diagnostic angiography and PCI) | immediately after the intervention/procedure |
Procedure time of MPFFR or invasive FFR measurement | Procedure time of MPFFR or invasive FFR measurement | immediately after the intervention/procedure |
Procedure time including the decision-making time for PCI following coronary angiography | Procedure time including the decision-making time for PCI following coronary angiography | immediately after the intervention/procedure |
Number of lesions interrogated | Number of lesions interrogated by MPFFR or invasive FFR | immediately after the intervention/procedure |
Number of used stents or drug-coated balloons | Number of used stents or drug-coated balloons | immediately after the intervention/procedure |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
19 Years
Sexos elegíveis
Todos
- Subject must be at least 19 years of age
- Eligible for coronary angiography and/or percutaneous coronary intervention.
- Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)
- Coronary artery disease in one or more native major epicardial vessels or their branches with reference vessel diameter of at least 2.5mm and with visually assessed coronary stenosis in which the physiological severity of the lesion is questionable (typically 40-90% diameter stenosis).
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
Patients unable to provide informed consent
Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons
Patients with coronary artery bypass grafting
Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
Patients with cardiogenic shock or cardiac arrest
Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
Patients with severe valvular heart disease requiring open heart surgery
Pregnant or lactating women
Angiographic exclusion criteria
- Culprit vessel of patients with ST-elevation myocardial infarction (target lesions in non-culprit vessel can be enrolled)
- Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled)
- Ostial stenosis in left man coronary artery or right coronary artery
- Severe tortuosity of any target vessel
- Severe overlap in the stenosed segment
- Poor image quality precluding identification of vessel contours
Samsung Medical Center195 estudos clínicos ativos para explorarResponsável pelo estudo
Joo Myung Lee, Investigador principal, Associate Professor, Samsung Medical Center
Contato central do estudo
Contato: Joo Myung Lee, MD, MPH, PhD, 0234102575, [email protected]
Contato: Seung Hun Lee, MD, PhD, 821064137449, [email protected]
25 Locais do estudo em 1 países
Select State
Korea University Anam Hospital, Seoul, Select State, South Korea
Inje University Haeundae Paik Hospital, Busan, South Korea
Changwon Fatima Hospital, Changwon, South Korea
Gyeongsang National University Changwon Hospital, Changwon, South Korea
Keimyung University Dongsan Hospital, Daegu, South Korea
Kyungpook National University Hospital, Daegu, South Korea
Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea
Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, South Korea
CHA Bundang Medical Center, Gyeonggi-do, South Korea
Wonkwang University Hospital, Iksan, South Korea
Inje University College of Medicine, Ilsan Paik Hospital, Ilsan, South Korea
Gachon University Gil Medical Center, Incheon, South Korea
Inha University Hospital, Incheon, South Korea
International St. Mary's Hospital, Incheon, South Korea
Presbyterian Medical Center, Jeonju, South Korea
Gyeongsang National University Hospital, Jinju, South Korea
Seoul National University Bundang Hospital, Seongnam, South Korea
Samsung Medical Center, Seoul, 06351, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
Korea University Guro Hospital, Seoul, South Korea
Seoul National University Boramae Medical Center, Seoul, South Korea
Ajou University Hospital, Suwon, South Korea
Uijeongbu ST. Mary's Hospital, Uijeongbu-si, South Korea
Ulsan University Hospital, Ulsan, South Korea
Wonju Severance Christian Hospital, Wŏnju, South Korea