Ireland
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Recruiting Observational

Resting Full-cycle Ratio (RFR)-Guided Revascularization

NCT06075160 · tracked via the Priya Life Science South Korea tracker
Sponsor
Sejong General Hospital
Phase
Observational
Started
2022-07-27
Last updated
2023-10-10

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Resting full-cycle ratio (RFR)-guided revascularizationFractional flow ratio (FFR)-guided revascularization

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.

Study 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

Sex
ALL
Min age
20 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • A composite of death from any cause, non-fatal myocardial infarction, or unplanned revascularization — At 2-year

Trial sites (1)

FacilityCityRegionStatus
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu Bucheon-si Gyeonggi-do Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06075160 on ClinicalTrials.gov ↗ ← All trials in South Korea