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Resting Full-cycle Ratio (RFR)-Guided Revascularization
Sponsor: Sejong General Hospital
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 patients with intermediate coronary stenosis.
Official title: Prospective Evaluation of Long-term Clinical Outcomes After Resting Full-cycle Ratio (RFR)-Guided Percutaneous Coronary Revascularization; A Multi-center, International, Single Arm Interventional, Comparing Registry (COMFORT Study)
Key Details
Gender
All
Age Range
20 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
1167
Start Date
2022-07-27
Completion Date
2026-12-31
Last Updated
2023-10-10
Healthy Volunteers
No
Conditions
Interventions
Resting full-cycle ratio (RFR)-guided revascularization
The decision of coronary intervention is based on an RFR cut-value of 0.89. If RFR ≤ 0.89, target lesion will be revascularized, and if RFR \> 0.89, PCI will be deferred. However, even if RFR ≤ 0.89, PCI can be deferred if the RFR gradient of the lesion ≤ 0.02, or if the diffused type of stenosis, because physiological gain is expected to be very low.
Fractional flow ratio (FFR)-guided revascularization
Study participants of FFR-guided PCI arm will be selected from a large-scaled, ongoing FFR registry. The decision of coronary intervention is based on an FFR cut-value of 0.80. If FFR ≤ 0.80, target lesion will be revascularized, and if RFR \> 0.80, PCI will be deferred.
Locations (1)
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, South Korea