QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial

NCT07635407 · tracked via the Priya Life Science China tracker

Sponsor

China National Center for Cardiovascular Diseases

Phase

Not applicable

Started

2026-06-02

Last updated

2026-07-06

Condition(s) studied

Coronary Artery DiseaseCoronary StenosisIschemic Heart Disease

Investigational drug(s) / intervention(s)

Virtual Stenting-Guided PCI OptimizationStandard Angiography-Guided PCI

Virtual Stenting-Guided PCI 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.

Standard Angiography-Guided PCI: Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Major Adverse Cardiovascular Events (MACE) — Within 1 year after PCI
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.

Trial sites (1)

Facility	City	Region	Status
Fuwai Hospital, CAMS & PUMC	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07635407 on ClinicalTrials.gov ↗ ← All trials in China