Last updated: October 3, 2023
Sponsor: Sejong General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Atherosclerosis
Coronary Artery Disease
Heart Disease
Treatment
Fractional flow ratio (FFR)-guided revascularization
Resting full-cycle ratio (RFR)-guided revascularization
Clinical Study ID
NCT06075160
COMFORT Vesion 2.6
Ages 20-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with intermediate coronary artery stenosis (visually 50-90% diameterstenosis) who decided to undergoing a RFR-guided coronary intervention according toclinical necessity
- Patients who voluntarily decided to participate in this study and signed informedconsent
Exclusion
Exclusion Criteria:
- 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 mayresult in protocol non-compliance
Study Design
Total Participants: 1167
Treatment Group(s): 2
Primary Treatment: Fractional flow ratio (FFR)-guided revascularization
Phase:
Study Start date:
July 27, 2022
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon, Gyeonggi-do 14574
Korea, Republic ofActive - Recruiting

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