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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Procedure: roadmap; Procedure: iFR/FFR

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongcheol Kim, MD, PhD; Phone Number: +823151898967; Email: yongcheol@yuhs.ac
• Study Contact Backup: Name: Ji Woong Roh, MD, PhD; Phone Number: +823151898792; Email: NOMGALDA@yuhs.ac

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, Korea, Republic of, 16995
      • Recruiting
      • Yongcheol Kim
      • Contact: Yongcheol Kim, MD; Phone Number: +823151898967; Email: yongcheol@yuhs.ac
      • Principal Investigator: Yongcheol Kim, MD, PhD
      • Sub-Investigator: Oh-Hyun Lee, MD
      • Sub-Investigator: Ji Woong Roh, MD, PhD
      • Sub-Investigator: Eui Im, MD
      • Sub-Investigator: Deok-Kyu Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tested using the roadmap system	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.
Active Comparator: tested without using the roadmap system; tested without using the roadmap system.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications related to the procedure	Complications related to the procedure	Through procedure completion, up to 24 hours
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
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
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
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
Total procedure time	Total procedure time	Through procedure completion, up to 24 hours
Total amount of contrast media usage	Total amount of contrast media usage	Through procedure completion, up to 24 hours
Total dose of radiation exposure	Total dose of radiation exposure	Through procedure completion, up to 24 hours

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Yongcheol Kim, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): November 27, 2025
• Study Completion (Estimated): November 27, 2025

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: iFR/FFR; Roadmap
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 9-2022-0134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No