Diagnostic Performance of Angiography-Derived Fractional Flow Reserve XA(FFRXA) Compared to Pressure Wire-Derived Fractional Flow Reserve: A Multicenter, Prospective, Single-blinded Trial
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008766
- Lead Sponsor
- Medipixel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
1.Patients with stable and unstable angina pectoris stabilized on medical therapy, or secondary evaluation of stenosis after acute myocardial infarction
2.Subjects at least 19 years of age
3.Able to provide written informed consent
4.Diameter stenosis 30%-90% by visual estimation
5.Reference vessel size = 2.0 mm in stenosed segment
1.Subjects with emergent PCI
2.Myocardial infarction within 72 hours
3.Severe asthma or severe chronic obstructive pulmonary disease
4.Allergy to contrast media or adenosine
5.Plasma creatinine 2.0mg/dL or more
6.Atrial fibrillation
7.Heart valve replacement
8.Complex congenital heart disease
9.Severe heart failure (NYHA = III), pulmonary edema, cardiogenic shock
10.Implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators, or cardiac resynchronization therapy devices
11.Participating in another trial currently or within 30 days
12.Subject belongs to a vulnerable population
13.Pregnant, breast feeding or childbearing potential.
14.Patients unsuitable for enrollment judged by the investigator
15.Prior PCI or CABG with stent in target vessel
16.Aorto-ostial lesion
17.Thrombus containing lesions
18.Poor image quality precluding contour detection
19.Severe tortuosity of target vessel (= 180° curvature observed in two or more consecutive major coronary arteries)
20.Severe overlap over stenosed segments
21.Good contrast filling not possible, myocardial bridging causing poor contour detection
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the ROC Curve
- Secondary Outcome Measures
Name Time Method Accuracy;Sensitivity;Specificity;Positive Predictive Value;Negative Predictive Value;Correlation Coefficient