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QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial (FAVOR-Virtual)

2026年7月2日 更新者：Ying Song、China National Center for Cardiovascular Diseases

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

1472

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100037
        • 招聘中
        • Fuwai Hospital, CAMS & PUMC
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
程序：Virtual Stenting-Guided PCI Optimization
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.
有源比较器：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.
程序：Standard Angiography-Guided PCI
Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Major Adverse Cardiovascular Events (MACE)
大体时间：Within 1 year after PCI
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
Within 1 year after PCI

次要结果测量

结果测量
措施说明
大体时间
Post-PCI Physiological Optimization
大体时间：Immediately after PCI
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.
Immediately after PCI
Cardiovascular Death or Nonfatal Myocardial Infarction
大体时间：Within 1 year after PCI
Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
Within 1 year after PCI
Myocardial Infarction
大体时间：Within 1 year after PCI
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).
Within 1 year after PCI

其他结果措施

结果测量
措施说明
大体时间
All-Cause Mortality
大体时间：Within 1 year after PCI
Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.
Within 1 year after PCI
Ischemia-Driven Repeat Revascularization
大体时间：Within 1 year after PCI
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.
Within 1 year after PCI
All revascularization
大体时间：Within 1 year after PCI
Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven
Within 1 year after PCI
Definite or Probable Stent Thrombosis
大体时间：Within 1 year after PCI
Definite or probable stent thrombosis according to ARC-2 definitions, including acute, subacute, late, and very late stent thrombosis.
Within 1 year after PCI
Major Bleeding Events
大体时间：Within 1 year after PCI
Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
Within 1 year after PCI
Health-Related Quality of Life - SAQ
大体时间：Baseline, 6 months, and 12 months after PCI
Quality of life assessed using the Seattle Angina Questionnaire (SAQ)
Baseline, 6 months, and 12 months after PCI
Health-Related Quality of Life - EQ-5D
大体时间：Baseline, 6 months, and 12 months after PCI
Quality of Life assessed by EuroQol Five-Dimensional Questionnaire (EQ-5D).
Baseline, 6 months, and 12 months after PCI
Quality-Adjusted Life Years (QALYs)
大体时间：Within 1 year after PCI
Cost-utility evaluation using quality-adjusted life years estimated from EQ-5D utility scores using the Japanese time trade-off (TTO) conversion algorithm.
Within 1 year after PCI
Healthcare Costs
大体时间：Baseline, 1 month, 6 months, and 12 months after PCI
Direct medical costs including index hospitalization costs, cardiovascular medication costs, outpatient costs, hospitalization costs, and MACE-related medical expenditures.
Baseline, 1 month, 6 months, and 12 months after PCI

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China National Center for Cardiovascular Diseases

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月2日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-2-4036

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Deidentified individual participant data underlying the results reported in publications, including demographic characteristics, baseline clinical variables, procedural information, and outcome measures, may be shared upon reasonable request.

IPD 共享时间框架

Beginning 12 months after publication and ending 5 years after publication

IPD 共享访问标准

Data will be made available to qualified researchers upon reasonable request and approval by the study steering committee, subject to institutional and regulatory requirements.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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