Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve

NARecruitingINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

July 31, 2023

Primary Completion Date

November 27, 2025

Study Completion Date

November 27, 2025

Conditions
Ischemic Heart Disease
Interventions
PROCEDURE

roadmap

"FFR and iFR tests using the roadmap system, or FFR and iFR tests without using the roadmap system.~Pressure wire into guiding catheter The equalization of the pressure wire with the aortic pressure(after placing the pressure wire on the tip of the guiding catheter and removal of contrast media by saline flushing) and the placement of the pressure wire on the distal of the blood vessel to measure iFR. After iFR measurement, the pressure wire was pulled back into the tip of the guiding catheter to check the presence of pressure drift. A final Pd/Pa between 0.97 and 1.03 is considered acceptable. Following confirming no pressure drift, a mode change will be done from iFR to FFR, and then a re-check of the time between the equalization of the pressure wire with the aortic pressure will be planned. In all lesions, FFR value were measured with hyperemia, achieved by intracoronary (IC) bolus injection of nicorandil (Sigmart®; Chugai Pharmaceutical Co., Ltd., Tokyo, Japan) 2 mg."

PROCEDURE

iFR/FFR

Patients undergoing pressure wire test with moderate stenosis. Pressure wire into guiding catheter The equalization of the pressure wire with the aortic pressure(after placing the pressure wire on the tip of the guiding catheter and removal of contrast media by saline flushing) and the placement of the pressure wire on the distal of the blood vessel to measure iFR. After iFR measurement, the pressure wire was pulled back into the tip of the guiding catheter to check the presence of pressure drift. A final Pd/Pa between 0.97 and 1.03 is considered acceptable. Following confirming no pressure drift, a mode change will be done from iFR to FFR, and then a re-check of the time between the equalization of the pressure wire with the aortic pressure will be planned. In all lesions, FFR value were measured with hyperemia, achieved by intracoronary (IC) bolus injection of nicorandil (Sigmart®; Chugai Pharmaceutical Co., Ltd., Tokyo, Japan) 2 mg.

Trial Locations (1)

16995

RECRUITING

Yongcheol Kim, Yongin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Philips Healthcare

INDUSTRY

lead

Yonsei University

OTHER