Coronary Stenosis
Conditions
Brief summary
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.
Detailed description
The present study is a single arm, open label, prospective trial. Measurement of FFR during invasive cardiac catheterization represents the gold standard for assessment of the hemodynamic significance of coronary artery lesions. As we know, the major disadvantage of FFR is that it has to be measured invasively. CardioSimFFRct Analysis software is a non-invasive method to determine FFR which computes the hemodynamic significance of Coronary Artery Disease (FFRCT) from coronary computed tomography angiography（CCTA）data of the subject by using computational fluid dynamics.The FFR derived from FFR-CT will be compared with invasive FFR as gold standard.Moreover CardioSimFFRct also simplifies the coronary artery into a one-dimensional piping model, omits grid engineering, and greatly reduces the complexity of pretreatment.Based on the pressure loss along the pipe flow and the local pressure loss, a fast method for FFR calculation in engineering is proposed. The calculation time can be reduced to several minutes. FFRct from CardioSimFFRct Analysis software is mainly based on CCTA images to image the coronary arteries. Through three-dimensional reconstruction of the coronary arteries and computational fluid Dynamics (CFD) technology, the simulation of blood flow in the blood vessels is realized to extract the coronary blood flow reserve score (FFR).FFRct has the following characteristics such as the FFR value can be measured noninvasively, without additional damage to patients, avoiding the risks brought by invasive surgery, and the side effects brought by drugs during invasive surgery.FFRct can realize the examination quickly, save the time of doctors' coronary functional assessment, and simplify the process of coronary functional assessment.It also has the function of three-dimensional reconstruction of blood vessels, which makes it convenient for users to view the whole structure of coronary arteries and make artificial correction.The results of FFRct have high repeatability and are easy for users to evaluate.
Interventions
DIAGNOSTIC_TESTFFR and FFRCT
All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.
Sponsors
Shengshi Technology, Co., Ltd, Hangzhou, China
CCRF Inc., Beijing, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects that participate in this study must fulfill all the following criteria: General inclusion criteria: * Age ≥18 years and ≤ 80 years; * Subject providing written informed consent; * After the researcher assessed the suspected presence of coronary artery stenosis, coronary angiography and CCTA examination were proposed. Angiographic inclusion criteria: * CCTA inspection should be performed on instruments with at least 64 multidetector rows; * CCTA images are clear and readable; * The diameter of coronary artery lesion stenosis was measured by CCTA image with 30%-90%; * The reference vessel diameter of coronary stenosis was ≥2.5mm by CCTA imaging.
Exclusion criteria
If subjects fulfill any of below criteria, this subject shall be exclude from this study. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity (subject level) of FFRCT | Measurement at Procedure/Baseline Visit | Sensitivity and specificity (subject level) for predicting the functional significance of coronary artery stenosis using CT-Derived Fractional Flow Reserve Score Analysis Software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC between FFRCT vs. FFR | Measurement at Procedure/Baseline Visit | Comparing the Area Under Curve(AUC) between FFRct and CCTA to determine the Functional significance of coronary stenosis. |
| Sensitivity and Specificity between FFRCT vs. FFR | Measurement at Procedure/Baseline Visit | Comparing the Sensitivity and Specificity which at the lesion level between FFRct and CCTA |
| Accuracy (lesion level and subject level) between FFRCT vs. FFR | Measurement at Procedure/Baseline Visit | Comparing the Accuracy which at the lesion level and subject level between FFRct and CCTA |
| Positive Predictive Value (PPV) between FFRCT vs. FFR | Measurement at Procedure/Baseline Visit | Comparing the positive predictive value (PPV) between FFRct and CCTA |
| Negative Predictive Value (NPV) between FFRCT vs. FFR | Measurement at Procedure/Baseline Visit | Comparing the negative predictive value (NPV) between FFRct and CCTA |
Countries
China
Contacts
Primary ContactYaling Han, professor
Outcome results
None listed