Resting Full-cycle Ratio (RFR)-Guided Revascularization
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)
Sejong General Hospital
1,167 participants
Jul 27, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria9
- 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
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT06075160