NCT05682118

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2023Nov 2026

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

December 27, 2022

Last Update Submit

February 8, 2026

Conditions

Ischemic Heart Disease

Keywords

iFR/FFRRoadmap

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • 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

    Through procedure completion, up to 24 hours

  • Total procedure time to assess functional significance using iFR/FFR pressure wire

    Through procedure completion, up to 24 hours

  • Total procedure time

    Through procedure completion, up to 24 hours

  • +3 more secondary outcomes

Study Arms (2)

tested using the roadmap system

EXPERIMENTAL

tested using the roadmap system

Procedure: roadmapProcedure: iFR/FFR

tested without using the roadmap system

ACTIVE COMPARATOR

tested without using the roadmap system.

Procedure: iFR/FFR

Interventions

roadmapPROCEDURE

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.

tested using the roadmap system
iFR/FFRPROCEDURE

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.

tested using the roadmap systemtested without using the roadmap system

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongcheol Kim

Yongin, Gyeonggi-do, 16995, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yongcheol Kim, MD, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongcheol Kim, MD, PhD

CONTACT

+823151898967yongcheol@yuhs.ac

Ji Woong Roh, MD, PhD

CONTACT

+823151898792NOMGALDA@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

July 31, 2023

Primary Completion (Estimated)

November 27, 2026

Study Completion (Estimated)

November 27, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The data set is available from the the corresponding author upon reasonable request.

Locations

KR(1)