Fractional Flow Reserve Coronary ArteryDisease
Conditions
Interventions
Gold Standard:Taking the coronary artery FFR measured by the gold standard pressure wire as the reference, and with FFR = 0.80 as the positive cut-off value and FFR > 0.80 as the negative cut-off valu
Index test:The S1 device, in conjunction with an imaging catheter, performs IVUS and OCT imaging simultaneously. The collected images are calculated using software to obtain the FFR value of the coron
Sponsors
The 2nd Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: General Selection Criteria: 1. Age over 18 years old (including 18 years old), less than or equal to 80 years old; 2. Patients who are expected to undergo elective percutaneous coronary intervention; 3. The patient's condition can tolerate IVUS-OCT synchronous imaging equipment examination and FFR examination; 4. Able to understand the purpose of this trial, voluntarily participate and sign the informed consent form. Image Selection Criteria (at least one of the unimodal and bimodal images meets the following conditions): 1. IVUS-OCT imaging intravascular image quality is clear and readable; 2. IVUS-OCT imaging vessel segment contains FFR measurement position; 3. IVUS-OCT imaging intravascular images contain the entire stenotic lesion of the blood vessel.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Pregnant or lactating women, and subjects (or their partners) who plan to become pregnant during the trial and within 6 months after the end of the trial, and do not agree to use contraception during the trial; 2. Those who have participated in other clinical studies or are participating in other clinical trials within 3 months; 3. Patients with acute myocardial infarction (within 30 days of the acute phase); 4. Patients with severe heart failure (NYHA III or NYHA IV or left ventricular ejection fraction <30%); 5. cTnI or cTnT level exceeds the upper limit of normal reference value within 72 hours before surgery, and is clinically significant; 6. Patients who have had coronary artery bypass grafting (CABG) surgery; 7. Patients diagnosed with bacteremia or sepsis; 8. Patients diagnosed with coronary artery spasm; 9. Abnormal coagulation function test judged by the investigator to be clinically significant; 10. Abnormal liver and kidney function tests judged by the investigator to be clinically significant; 11. Patients diagnosed with severe hemodynamic disorders or shock; 12. Patients with known allergies to contrast agents and other allergies that the surgeon believes may cause risk; 13. Patients with acute instability in clinical manifestations, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure state (systolic blood pressure less than 90mmHg), severe congestive heart failure, or acute pulmonary edema; 14. Patients with other severe diseases who are not suitable for clinical trials, such as complex congenital heart disease, myocardial bridge, long Q-T syndrome, severe asthma, severe chronic obstructive pulmonary disease or chronic severe obstructive pulmonary disease dependent on bronchodilators, and other patients with severe infections and acute and critical illnesses; 15. Primary lesions that do not conform to the diameter of the reference vessel of the stenotic segment of 2.0-4.0 mm and the diameter stenosis of 30%-90% by coronary angiography; 16. Accompanied by left main lesion, coronary artery opening lesion, severe tortuosity or calcification of the target vessel, complete occlusive lesion, diffuse lesion; 17. Patients with thrombus or dissection determined or suspected by target angiography; 18. Those who have stents implanted in the target vessel; 19. The minimum lumen diameter of the target vessel is less than 1.1mm; 20. Blood vessels that cannot obtain sufficient contrast fluid flow (TIMI blood flow level 2 and below); 21. Those who use balloon pre-dilatation before FFR measurement or imaging of the target vessel; 22. Those who cannot pass normally through the stenosis of the lesion using instruments, and other reasons that cause imaging or FFR measurement cannot be performed; 23. Those who do not observe the maximum congestion during the FFR recording process, or other reasons that do not obtain valid FFR measurement data; 24.Subjects who are not suitable for inclusion in this study in the opinion of the investigator. Image exclusion criteria 1. Poor quality of intravascular images obtained due to unsuccessful hemoclearance, quality of imaging equipment or imaging catheter or operational reasons; 2. Presence of vasospasm or injury during imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of the OUFRO, OUFRI, and OUFROI calculations for diagnosing functional myocardial ischemia were evaluated using FFR (0.80) as the gold standard and the subject level as the study unit; | — |
Secondary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of OUFRO, OUFRI and OUFROI calculations for the diagnosis of functional myocardial ischemia were evaluated using FFR (0.80) as the gold standard and the level of the diseased vessel as the research unit;Evaluate the OUFR calculation function with subject level and lesion vessel level as the study unit Positive predictive value, negative predictive value and area under the receiver operating characteristic curve (ROC) curve (AUC) for diagnosing functional myocardial ischemia;The accuracy of OUFRO, OUFRI and OUFROI calculations for diagnosing functional myocardial ischemia was evaluated using FFR (0.80) as the gold standard, and the subject level and the lesion vessel level were used as the study units, respectively;Incidence of adverse events and device defects; | — |
Countries
China
Contacts
Public ContactYu Bo
The 2nd Affiliated Hospital of Harbin Medical University
Outcome results
None listed