QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial (FAVOR-Virtual)
A Multicenter, Prospective, Randomized Controlled Trial of Preprocedural Physiological Optimization of Percutaneous Coronary Intervention Using Coronary Imaging-Physiology Fusion-Based Virtual Stenting Technology
Coronary angiography-guided percutaneous coronary intervention (PCI) remains the standard treatment strategy for patients with coronary artery disease; however, suboptimal post-PCI physiological outcomes remain common and are associated with adverse cardiovascular prognosis. Quantitative Flow Ratio (QFR)-based virtual stenting technology enables simulation of post-intervention coronary physiology before PCI and may facilitate individualized optimization of stent implantation strategies.
This multicenter, prospective, randomized controlled trial aims to evaluate whether preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology improves clinical outcomes compared with conventional angiography-guided PCI. Eligible patients undergoing PCI for coronary artery disease will be randomized in a 1:1 ratio to either virtual stenting-guided PCI optimization or standard angiography-guided PCI.
The primary endpoint is major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization within 1 year after PCI. Secondary endpoints include post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life, procedural safety, and health economic outcomes.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Percutaneous coronary intervention (PCI) guided by coronary angiography remains the current standard treatment approach for coronary artery disease. However, angiographic optimization does not necessarily correspond to physiological optimization, and a considerable proportion of patients experience suboptimal post-PCI coronary physiological results, which are associated with increased risks of adverse cardiovascular events.
Quantitative Flow Ratio (QFR)-derived physiological assessment provides a non-wire, angiography-based method for functional evaluation of coronary lesions. Recent developments in virtual stenting technology enable simulation of residual coronary physiology after hypothetical stent implantation, thereby allowing preprocedural prediction of post-PCI QFR and optimization of interventional strategies.
The present study is a multicenter, prospective, randomized controlled superiority trial designed to evaluate whether coronary imaging-physiology fusion-based virtual stenting technology for preprocedural physiological optimization improves clinical outcomes compared with conventional angiography-guided PCI.
Approximately 1,472 participants with coronary artery disease undergoing PCI will be randomized in a 1:1 ratio to either: Virtual stenting-guided PCI optimization; or Standard angiography-guided PCI.
The primary endpoint is 1-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization.
Secondary endpoints include immediate post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life assessed by Seattle Angina Questionnaire (SAQ) and EuroQol Five-Dimensional Questionnaire (EQ-5D), procedural safety, and health economic outcomes.
Participants will be followed at 30 days, 6 months, and 12 months after PCI. The study will also evaluate concordance between predicted post-PCI QFR derived from virtual stenting and actual postprocedural physiological measurements, as well as changes in operator treatment strategies after physiological optimization.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ying Song, MD
- Número de teléfono: +86-10-68314466
- Correo electrónico: songying@fuwai.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100037
- Reclutamiento
- Fuwai Hospital, CAMS & PUMC
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Contacto:
- Ying Song, MD
- Número de teléfono: 8688396666
- Correo electrónico: songying@fuwai.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of coronary artery disease requiring percutaneous coronary intervention (PCI) according to current clinical practice.
- Presence of at least one target coronary lesion considered suitable for PCI and evaluable by angiography-derived Quantitative Flow Ratio (QFR).
- Ability to undergo coronary angiography and PCI. Provision of written informed consent before study participation.
Exclusion Criteria:
- Contraindications to PCI or inability to undergo coronary intervention. Severe renal dysfunction or other conditions making angiographic procedures unsuitable.
- High bleeding risk judged by investigators.
- Inability to complete follow-up or comply with study procedures.
- Life expectancy less than 1 year due to non-cardiovascular comorbidities.
- Participation in another interventional clinical trial that may interfere with study outcomes.
- Coronary anatomy unsuitable for QFR-based virtual stenting analysis.
- Any condition judged by investigators to make study participation inappropriate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Virtual Stenting-Guided PCI Optimization
Participants randomized to the experimental group will undergo coronary imaging-physiology fusion-based virtual stenting analysis before PCI.
Predicted post-PCI physiological outcomes will be used to optimize interventional strategies, including lesion coverage, stent length, stent position, and procedural planning before stent implantation.
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Preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology based on angiography-derived Quantitative Flow Ratio (QFR) assessment to guide stent implantation strategy.
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Comparador activo: Angiography-Guided PCI
Participants randomized to the control group will undergo PCI according to standard angiographic guidance and operator judgment without virtual stenting-guided physiological optimization.
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Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: Within 1 year after PCI
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Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
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Within 1 year after PCI
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-PCI Physiological Optimization
Periodo de tiempo: Immediately after PCI
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Successful physiological optimization defined as postprocedural TIMI grade 3 flow and post-PCI Quantitative Flow Ratio (QFR) ≥0.90 in the target vessel immediately after PCI.
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Immediately after PCI
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Cardiovascular Death or Nonfatal Myocardial Infarction
Periodo de tiempo: Within 1 year after PCI
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Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
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Within 1 year after PCI
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Myocardial Infarction
Periodo de tiempo: Within 1 year after PCI
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This includes perioperative myocardial infarction and non-fatal myocardial infarction (including target vessel and non-target vessel related myocardial infarction) (30 days, 6 months, and 1 year postoperatively).
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Within 1 year after PCI
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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All-Cause Mortality
Periodo de tiempo: Within 1 year after PCI
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Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.
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Within 1 year after PCI
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Ischemia-Driven Repeat Revascularization
Periodo de tiempo: Within 1 year after PCI
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Repeat coronary revascularization (PCI or CABG) associated with ischemic symptoms, positive functional testing, angiographic stenosis ≥50% with ischemic evidence, or stenosis ≥70% regardless of symptoms.
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Within 1 year after PCI
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All revascularization
Periodo de tiempo: Within 1 year after PCI
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Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven
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Within 1 year after PCI
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Definite or Probable Stent Thrombosis
Periodo de tiempo: Within 1 year after PCI
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Definite or probable stent thrombosis according to ARC-2 definitions, including acute, subacute, late, and very late stent thrombosis.
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Within 1 year after PCI
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Major Bleeding Events
Periodo de tiempo: Within 1 year after PCI
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Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
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Within 1 year after PCI
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Health-Related Quality of Life - SAQ
Periodo de tiempo: Baseline, 6 months, and 12 months after PCI
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Quality of life assessed using the Seattle Angina Questionnaire (SAQ)
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Baseline, 6 months, and 12 months after PCI
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Health-Related Quality of Life - EQ-5D
Periodo de tiempo: Baseline, 6 months, and 12 months after PCI
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Quality of Life assessed by EuroQol Five-Dimensional Questionnaire (EQ-5D).
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Baseline, 6 months, and 12 months after PCI
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Quality-Adjusted Life Years (QALYs)
Periodo de tiempo: Within 1 year after PCI
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Cost-utility evaluation using quality-adjusted life years estimated from EQ-5D utility scores using the Japanese time trade-off (TTO) conversion algorithm.
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Within 1 year after PCI
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Healthcare Costs
Periodo de tiempo: Baseline, 1 month, 6 months, and 12 months after PCI
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Direct medical costs including index hospitalization costs, cardiovascular medication costs, outpatient costs, hospitalization costs, and MACE-related medical expenditures.
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Baseline, 1 month, 6 months, and 12 months after PCI
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Más información
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Palabras clave
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Otros números de identificación del estudio
- 2026-2-4036
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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