Coronary Artery DiseaseFAVOR-VirtualNCT07635407
QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial
A study testing Virtual Stenting-Guided PCI Optimization and Standard Angiography-Guided PCI in people with Coronary Artery Disease and Coronary Stenosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Ischemic Heart Disease
- What is being tested?
- Virtual Stenting-Guided PCI Optimization and Standard Angiography-Guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,472 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100037
Ying Song, MD, 8688396666, songying@fuwai.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Virtual Stenting-Guided PCI Optimization, Standard Angiography-Guided PCI
- Keywords
- Percutaneous Coronary Intervention, Quantitative Flow Ratio, Virtual Stenting, Coronary Physiology, Coronary Artery Disease, Physiological Optimization, Functional Revascularization
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Stenting-Guided PCI OptimizationProcedure or surgery
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.
Standard Angiography-Guided PCIProcedure or surgery
Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Stenting-Guided PCI Optimization | Experimental | 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. Receives: Procedure: Virtual Stenting-Guided PCI Optimization |
| Angiography-Guided PCI | Active comparator | Participants randomized to the control group will undergo PCI according to standard angiographic guidance and operator judgment without virtual stenting-guided physiological optimization. Receives: Procedure: Standard Angiography-Guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
Measured: Within 1 year after PCI
Secondary outcomes (3)
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.
Measured: Immediately after PCI
Cardiovascular Death or Nonfatal Myocardial Infarction
Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
Measured: 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).
Measured: Within 1 year after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start2 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either coronary imaging-physiology fusion-based virtual stenting-guided preprocedural PCI optimization or standard angiography-guided PCI. Treatment assignment will remain fixed throughout study participation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ying Song, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635407
- Sponsor's protocol ID
- 2026-2-4036
- Acronym
- FAVOR-Virtual
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial of Preprocedural Physiological Optimization of Percutaneous Coronary Intervention Using Coronary Imaging-Physiology Fusion-Based Virtual Stenting Technology
- ClinicalTrials.gov ID
- NCT07635407
- Acronym / sponsor ID
- FAVOR-Virtual / 2026-2-4036
- Keywords
- Percutaneous Coronary Intervention, Quantitative Flow Ratio, Virtual Stenting, Coronary Physiology, Coronary Artery Disease, Physiological Optimization, Functional Revascularization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,472 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either coronary imaging-physiology fusion-based virtual stenting-guided preprocedural PCI optimization or standard angiography-guided PCI. Treatment assignment will remain fixed throughout study participation.
| Arm | Type | Receives |
|---|---|---|
| Virtual Stenting-Guided PCI Optimization | Experimental | Procedure: Virtual Stenting-Guided PCI OptimizationParticipants 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 comparator | Procedure: Standard Angiography-Guided PCIParticipants randomized to the control group will undergo PCI according to standard angiographic guidance and operator judgment without virtual stenting-guided physiological optimization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Stenting-Guided PCI OptimizationPreprocedural 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. | Procedure or surgery | Virtual Stenting-Guided PCI Optimization |
| Standard Angiography-Guided PCIConventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization. | Procedure or surgery | Angiography-Guided PCI |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: Within 1 year after PCI
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
3 secondary outcomes
Post-PCI Physiological Optimization
Time frame: Immediately after PCI
Cardiovascular Death or Nonfatal Myocardial Infarction
Time frame: Within 1 year after PCI
Myocardial Infarction
Time frame: Within 1 year after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Stenting-Guided PCI Optimization and Standard Angiography-Guided PCI in people with Coronary Artery Disease and Coronary Stenosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Song, MD (+86-10-68314466, songying@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: Within 1 year after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.