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
1 other identifier
interventional
1,472
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2028
June 9, 2026
June 1, 2026
2.5 years
June 1, 2026
June 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Post-PCI Physiological Optimization
Immediately after PCI
Cardiovascular Death or Nonfatal Myocardial Infarction
Within 1 year after PCI
Myocardial Infarction
Within 1 year after PCI
Other Outcomes (9)
All-Cause Mortality
Within 1 year after PCI
Ischemia-Driven Repeat Revascularization
Within 1 year after PCI
All revascularization
Within 1 year after PCI
- +6 more other outcomes
Study Arms (2)
Virtual Stenting-Guided PCI Optimization
EXPERIMENTALParticipants 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.
Angiography-Guided PCI
ACTIVE COMPARATORParticipants randomized to the control group will undergo PCI according to standard angiographic guidance and operator judgment without virtual stenting-guided physiological optimization.
Interventions
Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the procedural nature of PCI, treating operators cannot be blinded to treatment allocation. Participants and clinical outcome assessors will remain blinded to treatment assignment during follow-up. Endpoint adjudication will be performed by blinded assessors.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 9, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 12 months after publication and ending 5 years after publication
- 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.
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.