NCT07635407 QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial
| NCT ID | NCT07635407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,472 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,472 participants in total. It began in 2026-06-02 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07635407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07635407 currently recruiting?
Yes, NCT07635407 is actively recruiting participants. Contact the research team at songying@fuwai.com for enrollment information.
Where is the NCT07635407 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07635407 clinical trial?
NCT07635407 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 1,472 participants.