Comparing IVUS-Guided Versus FFR-Guided Stent Placement After Angiography-Derived FFR Decision in Coronary Artery Disease Patients

What this Trial Is About

This research aims to compare two strategies for guiding stent placement in patients with coronary artery disease fractional flow reserve FFR-guided strategy versus intravascular ultrasound IVUS-guided stent implantation after angiography-derived FFR-based decision-making. The study focuses on patients with coronary artery stenosis and evaluates whether IVUS-guided stent implantation can reduce the rate of adverse combined outcomes compared to FFR-guided percutaneous coronary intervention PCI. Participants will be divided into two groups. In the experimental group, PCI is performed if angiography-derived FFR is 0.80 or less, and stent placement is optimized using IVUS based on criteria like plaque burden and minimum stent area. In the control group, PCI is performed if FFR is 0.80 or less, with optimization guided by FFR measurements after PCI. Stenting is deferred if the FFR or angiography-derived FFR is greater than 0.80. The trial is designed to enroll about 1,942 patients, randomly assigned equally to each group, with a follow-up period extending up to 60 months. During the study, participants will be monitored and assessed for patient-oriented composite outcomes including death, heart attack, or need for further revascularization at 24 months, with additional evaluations continuing through 60 months. Researchers will also examine individual components of these outcomes, target vessel failure, cost-effectiveness, and other cardiovascular events. Safety and clinical outcomes will be tracked carefully throughout the study duration, which includes 24 months for patient enrollment and 24 months for follow-up after randomization.

FFR Versus IVUS With Angiography-Derived FFR for Clinical Outcomes in Patients With Coronary Artery Disease