Diagnostic Performance of Angiography-Derived Fractional Flow Reserve XA(FFRXA) Compared to Pressure Wire-Derived Fractional Flow Reserve: A Multicenter, Prospective, Single-blinded Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008766

Enrollment

240

Registered

2023-09-04

Start date

2022-12-28

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Invasive coronary angiography is performed according to the standard practice guidelines. For the lesions meeting the angiographic criteria, two angiographic projections (at least 30°

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Area under the ROC Curve	—

Secondary

Measure	Time frame
Accuracy;Sensitivity;Specificity;Positive Predictive Value;Negative Predictive Value;Correlation Coefficient	—

Countries

Korea, Republic of

Contacts

Public ContactSi-Hyuk Kang

Seoul National University Bundang Hospital

eandp303@snu.ac.kr+82-31-787-7027

Outcome results