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RECRUITINGOBSERVATIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 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 may result in protocol non-compliance

Treatments Being Tested

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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