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

Not Applicable

Recruiting

• Conditions: Ischemic Heart Disease
• Interventions: Procedure: iFR/FFR; Procedure: roadmap

• Registration Number: NCT05682118
• Lead Sponsor: Yonsei University

Brief 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.

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 Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Study Start: 2023-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-11-27
• Study Completion: 2025-11-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tested without using the roadmap system	iFR/FFR	tested without using the roadmap system.
tested using the roadmap system	roadmap	tested using the roadmap system
tested using the roadmap system	iFR/FFR	tested using the roadmap system

Primary Outcome Measures

Name	Time	Method
iFR time	Through procedure completion, up to 24 hours	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	Through procedure completion, up to 24 hours	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 Outcome Measures

Name	Time	Method
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	Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel
Success rate of placement of the pressure wire on the distal of the blood vessel to measure iFR/FFR	Through procedure completion, up to 24 hours	The success rate of advancing pressure wire to a target vessel distally
Total dose of radiation exposure	Through procedure completion, up to 24 hours	Total dose of radiation exposure
Total procedure time to assess functional significance using iFR/FFR pressure wire	Through procedure completion, up to 24 hours	Total procedure time between insertion and out of guiding catheter via a sheath
Total amount of contrast media usage	Through procedure completion, up to 24 hours	Total amount of contrast media usage
Complications related to the procedure	Through procedure completion, up to 24 hours	Complications related to the procedure
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	The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel
Total procedure time	Through procedure completion, up to 24 hours	Total procedure time

Trial Locations

Locations (1)

Yongcheol Kim; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of