Status:
RECRUITING
Resting Full-cycle Ratio (RFR)-Guided Revascularization
Lead Sponsor:
Sejong General Hospital
Collaborating Sponsors:
Wonju Severance Christian Hospital
Hospital San Carlos, Madrid
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20-90 years
Brief Summary
The purpose of this study is to compare the clinical outcomes of a 2-year follow-up to determine whether RFR-guided coronary intervention is non-inferior to FFR-guided coronary intervention in patient...
Detailed Description
Myocardial ischemia is a key determinant of clinical prognosis in patients with coronary artery disease. In this regard, functional assessment of intermediate coronary stenoses with transtenotic press...
Eligibility Criteria
Inclusion
- Patients with intermediate coronary artery stenosis (visually 50-90% diameter stenosis) who decided to undergoing a RFR-guided coronary intervention according to clinical necessity
- Patients who voluntarily decided to participate in this study and signed informed consent
Exclusion
- Severe left ventricular systolic dysfunction (LVEF \<30%)
- Cardiogenic shock
- Culprit vessel in acute coronary syndrome
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Symptomatic valvular heart disease or cardiomyopathy
- Hemodynamic instability at the time of intervention (heart rate \<50 beats per minute, systolic blood pressure \<90mmHg)
- Previous CABG with patent grafts to the interrogated vessel
- Pregnancy or breastfeeding
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance
Key Trial Info
Start Date :
July 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1167 Patients enrolled
Trial Details
Trial ID
NCT06075160
Start Date
July 27 2022
End Date
December 31 2026
Last Update
October 10 2023
Active Locations (1)
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1
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, South Korea, 14574