NCT05857904

Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,648 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Angina, Stable
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CT-FFR	CT -FFR(coronary computed tomography angiography drived fractional flow reserve derived) uses routine coronary computed tomography angiography (CTA) images and applies a specific algorithm to extract both anatomical and physiological information of the coronary arteries. By combining these two pieces of information, a fluid dynamics model of the coronary arteries can be established, allowing the calculation of FFR at any location of the coronary arteries.
DEVICE	QFR	Quantitative flow ratio (QFR) is a new method for evaluating the functional significance of coronary artery stenosis based on angiography. It can be used for real-time detection of hemodynamic abnormalities in the coronary arteries in the catheterization lab. Unlike traditional methods that require the use of pressure wires and vasodilators such as adenosine, the QFR examination process only requires routine coronary angiography. By reconstructing the three-dimensional structure of the blood vessels and analyzing the hemodynamics, the QFR can evaluate the fractional flow reserve (FFR) without the need for pressure wires and vasodilators.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2028-05-01
• First posted: 2023-05-15
• Last updated: 2023-05-15

Locations

1 site across 1 country: China