QFR-guided virtual stenting to optimize PCI before the procedure
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
Run by China National Center for Cardiovascular Diseases · NCT07635407 · Data updated 2026-11-12
We’re testing whether using QFR-based virtual stenting before PCI can improve heart-procedure outcomes compared with standard angiography planning in adults with coronary artery disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1472 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07635407 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with coronary artery disease requiring PCI and at least one target lesion evaluable by QFR who can undergo angiography and PCI.
✕Probably not a fit
Patients whose anatomy or comorbidities limit the benefit of physiology-guided planning or who do not experience suboptimal post-PCI physiology may see no added advantage.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter trial compares virtual stenting-guided PCI optimization to conventional angiography-guided PCI. It uses imaging-physiology fusion to simulate post-PCI physiology and guide stent strategy before intervention. Eligible adults with coronary artery disease undergoing PCI are randomized 1:1 to receive either the virtual stenting approach or standard care. The primary endpoint is 1-year major adverse cardiovascular events. The study aims to determine if preprocedural physiological optimization can translate into better clinical outcomes.
Why it matters
Potential benefit: If successful, patients may experience fewer major adverse cardiovascular events after PCI through more precise, physiology-guided stent planning.
How similar studies have gone: Previous work in physiology-guided PCI and noninvasive QFR-based assessments suggests potential benefits, but direct preprocedural virtual stenting optimization is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Ying Song, MD
- Email: songying@fuwai.com
- Phone: +86-10-68314466
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.