Coronary artery stenosis
Conditions
Interventions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General: (1) Aged at least 18 years, male or female; (2) Subjects with stable and unstable angina pectoris; (3) Subjects volunteer to participate in the clinical trial and sign informed consent. Angiographic: (1)At least one stenosis with diameter stenosis of 30%-90% by visual estimate; (2)Reference vessel size = 2 mm in stenotic segment by visual estimate.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: (1) Ineligible for diagnostic intervention or FFR examination; (2) Myocardial infarction within 6 days; (3) Left ventricular ejection fraction = 50%; (4) eGFR <60 ml/min (1.73 m2); (5) Severe coagulopathy or bleeding disorders; (6) Allergic to iodine contrast agents or adenosine or ATP; (7) The subject has participated in or is participating in other clinical trials in the past 1 month; (8) The subject has other conditions that are not suitable for clinical trials. Angiographic Exclusion Criteria: (1) The interrogated stenosis is caused by myocardial bridge; (2) Ostial lesions less than 3 mm to the aorta; (3) Contrast agent insufficiency, vascular overlap or severe distortion of the interrogated vessel, and poor angiographic image quality precluding contour detection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of online (CAFFR) measured by Coronary Angiography Fractional Flow Reserve(CAFFR) measured by Coronary Analysis System and Disposable Blood Pressure Transducer when compared to FFR as the reference standard.;The ROC curve and the area under the curve of Coronary Analysis System in assessment of coronary stenosis with FFR as the contrast; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute and relative error levels of CAFFR and FFR;The accuracy of core laboratory's off-line calculation of CAFFR value with FFR as the contrast.;Suitability of Disposable Blood Pressure Transducer and tee;The researchers' satisfaction with the use of Coronary Analysis Systems and Disposable Blood Pressure Transducer.;The difference value between mean aortic pressure values at the mouth of the coronary artery measured by Disposable Blood Pressure Transducer (test product) and Disposable Pressure Transducer(control product); | — |
Countries
China
Contacts
Public ContactYong Huo
Peking University First Hospital
Outcome results
None listed