QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease, Coronary Stenosis, Ischemic Heart Disease
In brief
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.
Key facts
- Study ID
- NCT07635407
- Run by
- China National Center for Cardiovascular Diseases
- People needed
- 1472
- Starts
- 2026-06-02
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Fuwai Hospital, CAMS & PUMC — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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