The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis

This is an interventional diagnostic trial for Coronary Stenosis Read More

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 exclusion criteria:

• Pregnant and breast-feeding women;
• Previous ST-segment elevation myocardial infarction 30 days before CCTA examination, and a history of non-ST-segment elevation myocardial infarction 7 days before CCTA examination;
• Prior Coronary Artery Bypass Graft（CABG）,Pacemaker, Implantable Cardioverter Defibrillator（ICD）, Artificial Valve Implantation;
• Hypertrophic obstructive cardiomyopathy;
• Heart failure(NYHA≥III or Left Ventricular Ejection Fraction（LVEF）< 40%);
• Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia and other arrhythmias;
• Body mass index >35kg/m2;
• Serum creatinine >178µmol/L or 2mg/dl;
• Allergies or contraindications to contrast agents are known;
• Subject who received Nicorandil within 2 weeks prior to invasive FFR examination;
• Any other conditions that are not suitable for the study.

Angiographic exclusion criteria:

• The quality of CT imaging is not good enough to extract coronary blood vessel trees;
• Visual measurement of coronary lesion diameter stenosis > 90% by CCTA imaging;
• The target lesions were diffuse lesions, and the lesion length was ≥ 30mm (visual measurement);
• There were ≥ 2 stenosis lesions in the target vessel;
• Stent implantation in the target vessel;
• Lesions involving aneurysms or myocardial Bridges;
• The target vessel is very tortuous and it is difficult to predict the passage of the pressure guide wire.
• Left main disease;
• Patients with acute coronary syndrome after CCTA examination and before invasive FFR examination;
• Severe calcification(i.e Diffuse calcification ,Local or segmental calcification)