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

Ischemic Heart Disease Clinical Trial

— ROAD-IFR  

Official title:

Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve: A Single-Center, Randomized Study (ROAD-IFR Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682118
• Other study ID #: 9-2022-0134
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: November 27, 2025

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Yongcheol Kim, MD, PhD
• Phone: +823151898967
• Email: yongcheol[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: November 27, 2025
• Est. primary completion date: November 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yongcheol Kim	Yongin	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Philips Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through procedure completion, up to 24 hours
Primary	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	Through procedure completion, up to 24 hours
Secondary	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	Through procedure completion, up to 24 hours
Secondary	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	Through procedure completion, up to 24 hours
Secondary	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	Through procedure completion, up to 24 hours
Secondary	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	Through procedure completion, up to 24 hours
Secondary	Total procedure time	Total procedure time	Through procedure completion, up to 24 hours
Secondary	Total amount of contrast media usage	Total amount of contrast media usage	Through procedure completion, up to 24 hours
Secondary	Total dose of radiation exposure	Total dose of radiation exposure	Through procedure completion, up to 24 hours
Secondary	Complications related to the procedure	Complications related to the procedure	Through procedure completion, up to 24 hours