Actively Recruiting
Comparing Virtual Stenting-Guided and Standard Angiography-Guided PCI in Coronary Artery Disease A Randomized Controlled Trial to Optimize Percutaneous Coronary Intervention
Led by China National Center for Cardiovascular Diseases · Updated on 2026-07-06
1472
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether using a coronary imaging-physiology fusion-based virtual stenting technology before percutaneous coronary intervention PCI can improve clinical outcomes for patients with coronary artery disease compared to the current standard PCI guided by coronary angiography alone. This multicenter, prospective, randomized controlled trial aims to address suboptimal post-PCI physiological results, which are linked to worse cardiovascular prognosis. Approximately 1,472 participants undergoing PCI will be enrolled and randomly assigned to one of two groups. Participants in the experimental group will have their PCI optimized using virtual stenting technology that simulates post-intervention coronary physiology based on Quantitative Flow Ratio QFR assessment. This helps guide decisions on lesion coverage, stent length, and positioning before the actual stent implantation. The control group will receive the standard PCI guided by angiography without the use of virtual stenting. The study will follow participants for one year after PCI to evaluate outcomes. During the study, participants will be assessed at 30 days, 6 months, and 12 months post-PCI. Researchers will measure major adverse cardiovascular events MACE, including all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization. Secondary outcomes include immediate post-PCI physiological optimization, cardiovascular events, quality of life assessed by questionnaires, procedural safety, and health economic outcomes. The study also evaluates how well the virtual stenting predictions match actual post-PCI physiology and observes changes in treatment strategies after optimization.
CONDITIONS
Brief Title
QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial
Research Team
Y
Ying Song, MD
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