Resting Full-cycle Ratio (RFR)-Guided Revascularization

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.

Conditions

• Coronary Artery Disease

Interventions

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.

Sponsors & Collaborators

• Wonju Severance Christian Hospital

  collaborator OTHER

• Hospital San Carlos, Madrid

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Dong-A University Hospital

  collaborator OTHER

• Gyeongsang National University Hospital

  collaborator OTHER

• Soon Chun Hyang University

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Kosin University Gospel Hospital

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

• Sejong General Hospital

  lead OTHER

Eligibility

Min Age

20 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-27

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• South Korea

Study Locations