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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Stenosis
• Intervention / Treatment: Procedure: Virtual Stenting-Guided PCI Optimization; Procedure: Standard Angiography-Guided PCI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1472
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Song, MD; Phone Number: +86-10-68314466; Email: songying@fuwai.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Fuwai Hospital, CAMS & PUMC
      • Contact: Ying Song, MD; Phone Number: 8688396666; Email: songying@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.	Within 1 year after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-PCI Physiological Optimization	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	Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.	Within 1 year after PCI
Myocardial Infarction	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality	Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.	Within 1 year after PCI
Ischemia-Driven Repeat Revascularization	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	Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven	Within 1 year after PCI
Definite or Probable Stent Thrombosis	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	Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.	Within 1 year after PCI
Health-Related Quality of Life - SAQ	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	Quality of Life assessed by EuroQol Five-Dimensional Questionnaire (EQ-5D).	Baseline, 6 months, and 12 months after PCI
Quality-Adjusted Life Years (QALYs)	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	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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Quantitative Flow Ratio; Coronary Physiology; Virtual Stenting; Physiological Optimization; Functional Revascularization
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis; Myocardial Ischemia
• Other Study ID Numbers: 2026-2-4036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: Beginning 12 months after publication and ending 5 years after publication
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No