About this trial
In patients with 50-90% stenosis of the coronary artery, the coronary roadmap (dynamic roadmap) is performed when the conventional fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are performed. coronary roadmap system) to confirm the effectiveness of the function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 19 years or older
Patients with stable angina, including asymptomatic ischemic heart disease, who have 50-90% stenosis of the causative vessel by coronary angiography
Acute coronary syndrome patients with multivessel disease and 50-90% stenosis of non-caused vessels that did not cause acute coronary syndrome
Patients who voluntarily decided to participate in this study and gave written consent to the subject consent form
Disqualifiers
Patients with acute coronary syndrome and single vessel disease
Patients who have undergone previous coronary artery bypass grafting
Poor coronary blood flow (TIMI grade ≤ 2)
If life expectancy is less than one year
Trial design
Parallel
Treatments tested in this trial
roadmap
Procedure/SurgeryFFR 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.
iFR/FFR
Procedure/SurgeryPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
iFR time
iFR time: the time interval between the pressure wire into the guiding catheter and the placement of the pressure wire on the distal of the blood vessel to measure iFR
FFR time
FFR time: the time interval between the equalization of the pressure wire for FFR and the placement of the pressure wire on the distal of the blood vessel to measure FFR
Secondary outcomes
Success rate of placement of the pressure wire on the distal of the blood vessel to measure iFR/FFR
The success rate of advancing pressure wire to a target vessel distally
Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel
Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel
The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel
The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel
Total procedure time to assess functional significance using iFR/FFR pressure wire
Total procedure time between insertion and out of guiding catheter via a sheath
Locations
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Sponsors and contacts
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Yonsei University
Lead sponsor
Philips Healthcare
Collaborator