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Clinical Trial Summary

This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).

Clinical Trial Description

This study is a multicenter, prospective, blinded, randomized controlled trial with event-driven non-inferiority design (blinding of clinical evaluators). A total of 4,648 participants will be recruited and randomly assigned to the CT-FFR guided group or the QFR guided group in a 1:1 ratio. Patients in the experimental group (CT-FFR guided group) will undergo three-dimensional reconstruction of coronary arteries and CT-FFR calculation using coronary CT angiography (CCTA) images and the RuiXin-FFR software. The CT-FFR results will be interpreted and analyzed by the researchers. If the CT-FFR value is >0.8, patients will receive medical therapy only, while if the CT-FFR value is ≤0.8, patients will undergo further coronary angiography to determine the appropriate treatment strategy (PCI, CABG, or medical therapy), based on the anatomical features of the lesion and CT-FFR results. Patients in the control group (QFR guided group) will undergo invasive coronary angiography (ICA) and QFR calculation based on ICA images. If the QFR value is ≤0.8 and the lesion is suitable for intervention, patients will receive PCI, while if the QFR value is >0.8, medical therapy will be recommended. Both groups will be followed up for clinical outcomes, health economics indicators, and quality of life at 1 month, 6 months, 1 year, 2 years, and 3 years. The occurrence of major adverse cardiovascular events (MACE) will be compared between the two groups. The study will also assess the effectiveness, safety, and economic value of CT-FFR in guiding diagnosis and treatment decisions for patients with stable angina, using QFR guided PCI as a control, with a non-inferiority comparison. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05857904
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact chenguang Li, doctor
Phone 13816767665
Status Not yet recruiting
Phase N/A
Start date May 2023
Completion date May 2028

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