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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • roadmap

    Procedure/Surgery

    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.

  • iFR/FFR

    Procedure/Surgery

    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.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: tested using the roadmap systemExperimental treatment 2 interventions
Group B: tested without using the roadmap systemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through procedure completion, up to 24 hours
2

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

Time frame
Through procedure completion, up to 24 hours

Secondary outcomes

1

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

Time frame
Through procedure completion, up to 24 hours
2

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

Time frame
Through procedure completion, up to 24 hours
3

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

Time frame
Through procedure completion, up to 24 hours
4

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

Time frame
Through procedure completion, up to 24 hours

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Yongcheol KimRecruiting16995, Yongin, Gyeonggi-doSouth Korea

Sponsors and contacts

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Yonsei University

Lead sponsor

Philips Healthcare

Collaborator