The overall purpose of Flash FFR Ⅱ is to investigate whether coronary angiography-derived fractional flow reserve (caFFR), compared with fractional flow reserve (FFR) measured by a pressure wire, has non-inferior clinical effect and cost benefit in guiding the percutaneous coronary intervention (PCI) for patients with moderate coronary artery stenosis in terms of long-term clinical prognosis.
Flash FFR Ⅱ is a prospective, multicenter, blinded, randomized, non-inferiority trial. Eligible patients with moderate coronary artery stenosis will be included in the study and randomly assigned to either caFFR-guided group or FFR-guided group. Participant caFFR or FFR will be used to guide percutaneous coronary intervention (PCI) strategy. The rate of major cardiovascular adverse events (MACE) and the cost data will be collected during the long-term follow-up (2 years). MACE is defined as a composite of all-cause death, myocardial infarction (MI), unplanned revascularization. Clinical outcomes and cost-effectiveness will be compared between the two groups. A subgroup analysis is pre-set and included in the protocol, including age, sex, body mass index, diabetes mellitus, smoking status, mean aortic pressure (resting state), acute coronary syndrome, left ventricular ejection fraction, lesion site, lesion stenosis severity, target vessel reference diameter, small vessel lesion, blood flow velocity, PCI mode, and so on. The trial is equipped with a core laboratory. Some interesting sub-studies will be carried out, such as a comparison of laboratory and operator analysis results. If the trial results show non-inferiority, it should be noted that caFFR can bring new benefits to both operators and patients as a new index of physiological assessment of coronary artery stenosis severity with the advantages of lower cost, less risk, faster time, and less use of resources.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
2,132
caFFR is a new index of physiological assessment of coronary artery stenosis severity, based on angiographic images. Through two-dimensional analysis and three-dimensional reconstruction of two coronary angiography image series with an angle-off \> 30 degrees, combined with fluid mechanics, TIMI frame counting method, and optimized CFD algorithm, the pressure drop from coronary ostium to every point in the vessel can be obtained, and then the caFFR value of each point in the vessel can be computed. The cutoff value in this trial is caFFR ≤ 0.80 for myocardial ischemia.
FFR is a widely used, pressure-based functional assessment index of coronary stenoses obtained with an intracoronary pressure wire fitted with pressure sensors. The pressure wire passes through the stenosis and directly measures the pressure distal to the stenosis. FFR value can be obtained by combining the pressure at the coronary ostium and the distal pressure to the stenosis. The cutoff value in this trial is FFR ≤ 0.80 for myocardial ischemia.
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGXiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
COMPLETEDThe University of Hong Kong Shenzhen hospital
Shenzhen, Guangdong, China
RECRUITINGThe People's Hospital of Hebi
Hebi, Henan, China
RECRUITINGThe First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
RECRUITINGJiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
RECRUITINGQILU Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGZhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING...and 3 more locations
MACE
A composite of all-cause death, myocardial infarction (MI), and unplanned revascularization
Time frame: 1 year
MACE(excluding PCI-related MI)
A composite of all-cause death, myocardial infarction (excluding PCI-related), and unplanned revascularization
Time frame: 1 month, 1 year, 2 years
Death
Cardiovascular, non-cardiovascular, and undetermined death
Time frame: 1 month, 6 months, 1 year, 2 years
MI
Target vessel related and non-target vessel related MI
Time frame: 1 month, 6 months, 1 year, 2 years
Target vessel revascularization (TVR)
The ischemia driven and non-ischemia driven TVR
Time frame: 1 month, 6 months, 1 year, 2 years
Any coronary artery revascularization
The ischemia driven and non-ischemia driven revascularization
Time frame: 1 month, 6 months, 1 year, 2 years
Definite or probable stent thrombosis
Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase
Time frame: 1 month, 6 months, 1 year, 2 years
Evaluation of health economics
Cost-utility analysis and computation of incremental cost-effectiveness ratio.
Time frame: 1 month, 6 months, 1 year
Analysis of participant discomfort during the operation (none/mild/moderate/severe )
During the caFFR or FFR detection, the operator will ask the participant if there is discomfort (none/mild/moderate/severe ) and what kind of discomfort(such as palpitation, chest stuffy , nausea, dizziness, foreign body invasion ), and fill out a questionnaire after the operation.The discomfort of all participants caused by the use of drugs, intervention, etc. during the caFFR or FFR detection will be analyzed.
Time frame: During the operation
The changes of PCI strategy depending on caFFR/FFR information
Before randomization,the operators will be asked to provide their planned treatment strategy based on the angiographic information alone. After randomization and functional assessment,we will record how caFFR/FFR changed the treatment strategy.
Time frame: During the operation
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