Идёт набор NCT05682118

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

Без фазы С лечением Ischemic Heart Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: roadmap, iFR/FFR.
Кому может быть актуально: Состояния в реестре: Ischemic Heart Disease. Базовые параметры: от 19 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура 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 t
Процедура 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 drif

Первичные конечные точки

iFR time [Срок оценки: Through procedure completion, up to 24 hours]
FFR time [Срок оценки: Through procedure completion, up to 24 hours]

Вторичные конечные точки (8)

Success rate of placement of the pressure wire on the distal of the blood vessel to measure iFR/FFR [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Through procedure completion, up to 24 hours]
Total procedure time to assess functional significance using iFR/FFR pressure wire [Срок оценки: Through procedure completion, up to 24 hours]
Total procedure time [Срок оценки: Through procedure completion, up to 24 hours]
Total amount of contrast media usage [Срок оценки: Through procedure completion, up to 24 hours]
Total dose of radiation exposure [Срок оценки: Through procedure completion, up to 24 hours]
Complications related to the procedure [Срок оценки: Through procedure completion, up to 24 hours]

Критерии участия

Критерии включения

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