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临床试验/NCT05682118
NCT05682118招募中不适用

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)

Yonsei University1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2023年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
226
试验地点
1
主要终点
iFR time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

tested using the roadmap system

Experimental

tested using the roadmap system

干预措施: roadmap (Procedure)

tested using the roadmap system

Experimental

tested using the roadmap system

干预措施: iFR/FFR (Procedure)

tested without using the roadmap system

Active Comparator

tested without using the roadmap system.

干预措施: iFR/FFR (Procedure)

结局指标

主要结局

iFR time

时间窗: 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

时间窗: 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

次要结局

  • 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)
  • 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)
  • Total dose of radiation exposure(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 amount of contrast media usage(Through procedure completion, up to 24 hours)
  • Complications related to the procedure(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(Through procedure completion, up to 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongcheol Kim

Clinical Associate Professor

Yonsei University

研究点 (1)

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