Coronary heart disease
Conditions
Interventions
Gold Standard:fractional flow reserve,FFR
Index test:Flow reserve fraction based on OCT imaging
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years old; 2. Undergoing coronary angiography, with intraoperative plans to conduct FFR and OCT examinations for evaluation; 3. The target vessel diameter is 2 - 3.5 mm; 4. Visual stenosis of 30% - 90% detected by coronary angiography; 5. Being able to understand the purpose of the clinical study, voluntarily participating and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome within 72 hours in the target vessel, or chronic total occlusive lesions. 2. Left main coronary artery lesions. 3. Coronary ostial lesions (within 3 mm from the ostium). 4. The target vessel has previously undergone coronary artery bypass grafting. 5. Severe valvular heart disease. 6. Persistent coronary artery spasm or myocardial bridge in the target vessel. 7. A large amount of thrombus visible on coronary angiography. 8. Subjects planned to undergo other surgical procedures before OCT or FFR. 9. The OCT pullback imaging does not cover the complete lesion, the OCT imaging catheter cannot pass through, or the image quality is too poor to analyze. 10. The quality of the FFR pressure tracing results remains unacceptable even after adjustment. 11. Known allergy to contrast agents and related drugs such as ATP, adenosine, nitroglycerin, etc. 12. Subjects with a history of active peptic ulcer, cerebral hemorrhage or subarachnoid hemorrhage, stroke within the past six months, those with a bleeding tendency, and those with contraindications to antiplatelet agents and anticoagulant therapy who cannot receive anticoagulant treatment. 13. Female subjects who are pregnant or breastfeeding. 14. Presence of any other factors that the investigator deems inappropriate for inclusion in or completion of this clinical trial (such as having contraindications to coronary intervention procedures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of intravascular fractional flow reserve (VFR) based on OCT; | — |
Secondary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of VFR within the gray area of FFR measurement.;The average deviation between VFR and FFR;The area under the ROC curve (AUC) based on VFR diagnosis;The incidence of device defects; | — |
Countries
China
Contacts
Public ContactJian'an Wang
The Second Affiliated Hospital Zhejiang University School
Outcome results
None listed