Clinical trial NCT05682118: Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: iFR/FFR
Roadmap
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2023-01-12
Enrollment: 226
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size was calculated using effect size (Cohen's d) for the effectiveness of the dynamic coronary roadmap system for the guidance of the iFR and FFR. The effect size was assumed to be 0.4, which is a small to medium effect size. The sample size of 113 participants for each group was estimated to provide 90% power with a 2-sided type I error of 0.05.

This is a single-center randomized study and will be conducted in 226 patients with 50-90% coronary artery stenosis on angiography. Afterward, randomly assigned, 113 patients will be tested using the roadmap system, and 113 patients will be tested without using the roadmap system. Methods for measuring FFR and iFR and all PCI will use standardized testing and procedure methods.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: iFR time
timeFrame: Through procedure completion, up to 24 hours
measure: FFR time
timeFrame: Through procedure completion, up to 24 hours
Secondary outcomes:
measure: Success rate of placement of the pressure wire on the distal of the blood vessel to measure iFR/FFR
timeFrame: Through procedure completion, up to 24 hours
measure: Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel
timeFrame: Through procedure completion, up to 24 hours
measure: The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel
timeFrame: Through procedure completion, up to 24 hours
measure: Total procedure time to assess functional significance using iFR/FFR pressure wire
timeFrame: Through procedure completion, up to 24 hours
measure: Total procedure time
timeFrame: Through procedure completion, up to 24 hours
measure: Total amount of contrast media usage
timeFrame: Through procedure completion, up to 24 hours
measure: Total dose of radiation exposure
timeFrame: Through procedure completion, up to 24 hours
measure: Complications related to the procedure
timeFrame: Through procedure completion, up to 24 hours
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongcheol Kim
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Yongcheol Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: