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

Yonsei University

Status: Enrolling

Conditions: Ischemic Heart Disease

Treatments: Procedure: iFR/FFR; Procedure: roadmap

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05682118

9-2022-0134

Details and patient eligibility

About

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.

Full description

In coronary angiography, 50% or more stenosis of the causative vessel is observed in a patient with stable angina pectoris (SAP) or 50% or more stenosis of a non-causative vessel is observed in acute coronary syndrome (ACS) Based on 0.90, if it is less than 0.89, PCI is performed, and if it is 0.90 or more, drug treatment is performed. When the pressure wire tests are performed, the pressure wire is inserted from the origin of the blood vessel through the lesion to the distal portion, and the pressure wire is placed at the distal end of the blood vessel for measurement. In this process, there are many cases where the pressure wire escapes the branch blood vessel or does not pass through well. It takes a long time to stand up and evaluate stenosis, and in many cases, an additional contrast medium is used to additionally check blood vessel travel and to check the position and condition of the pressure wire. To overcome this, the software roadmap installed in the cardiac fluoroscopy device of the cardiac catheterization room can be helpful. However, there are currently no studies related to roadmaps in coronary artery examination. Therefore, in this study, we want to evaluate the effectiveness of the roadmap when examining FFR and iFR.

Enrollment: 226 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 19 years or older
2. Patients with stable angina, including asymptomatic ischemic heart disease, who have 50-90% stenosis of the causative vessel by coronary angiography
3. Acute coronary syndrome patients with multivessel disease and 50-90% stenosis of non-caused vessels that did not cause acute coronary syndrome
4. Patients who voluntarily decided to participate in this study and gave written consent to the subject consent form

Exclusion criteria

1. Patients with acute coronary syndrome and single vessel disease
2. Patients who have undergone previous coronary artery bypass grafting
3. Poor coronary blood flow (TIMI grade ≤ 2)
4. If life expectancy is less than one year
5. Women who are pregnant or wish to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

tested using the roadmap system

Experimental group

Description:

tested using the roadmap system

Treatment:

Procedure: roadmap

Procedure: iFR/FFR

tested without using the roadmap system

Active Comparator group

Description:

tested without using the roadmap system.

Treatment:

Procedure: iFR/FFR