A Blind Self Controlled Multicenter Clinical Trial on the Effectiveness and Safety of Noninvasive Flow Reserve Score Analysis Software for Coronary Angiography

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participants needed

340
sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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Updated on 19 February 2024

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stenosis

angiography

computed tomography angiography

coronary ct

Summary

This is a blind evaluation, self-control, multicenter clinical trial. 340 patients who need selective operation to evaluate the function of coronary artery were selected and measured with ctffr and FFR. The data of the experimental group was defined as: FFR value at the distal end of stenosis was obtained by calculating the original DICOM data of coronary CT angiography (CCTA) before operation with the non-invasive blood flow reserve analysis software of Hangzhou ArteryFlow Technology Co., Ltd. The gold standard group data is the clinical measured FFR (clinical gold standard) at the stenosis lesions. It is defined that when the coronary artery reaches the maximum congestion state, the pressure value at the distal end of the stenosis lesions is accurately measured by the guide wire with a pressure sensor, and the ratio value with the coronary mouth pressure is the FFR. By comparing the data of the experimental group and the data of the gold standard group, the effectiveness and safety of the devices in the experimental group were evaluated.

Details

Condition	Coronary heart disease
Age	18-75 years
Clinical Study Identifier	NCT04426396
Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	The age is 18-75 years old (including 18 and 75 years old)
	Subjects with clinical need and consent for coronary angiography
	Can provide the results of coronary CT angiography within 60 days or agree to carry out coronary CT angiography
	The subjects knew about the experiment and signed the informed consent voluntarily
Exclusion Criteria
	Patients who have had percutaneous coronary intervention (PCI)
	Patients who had CABG
	Acute coronary syndrome, such as acute ST segment elevation
	Severe tachycardia or arrhythmia
	Patients with severe hepatorenal insufficiency
	Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve
	Failure to perform invasive FFR examination or obtain FFR value due to various reasons
	Allergic to - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD
	Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure < 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema
	The CTA images of coronary artery showed that the stenosis rate was less than 30% or more than 90%, or the diameter of diseased segment was less than 2.0mm
	Ct-ffr can not be calculated because of the quality of CTA image
	Known pregnant and lactating women
	Having participated in other clinical trials within 3 months
	Other situations that the researchers judged were not suitable for inclusion

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A Blind Self Controlled Multicenter Clinical Trial on the Effectiveness and Safety of Noninvasive Flow Reserve Score Analysis Software for Coronary Angiography