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中等度狭窄の機能的病変評価による血行再建の指針

基本情報

NCT ID
NCT02053038
ステータス
不明
試験のフェーズ
該当なし
試験タイプ
介入
目標被験者数
2,500
治験依頼者名
Imperial College London

概要

Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But patients may have more than one narrowing and studies have shown that not all narrowings need to be treated. To identify the narrowings that need treating cardiologists sometimes quantify the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the pressure in the aorta to the pressure downstream of the narrowing).This technique requires the administration of drugs that add cost and time to the procedure and in some countries are simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR its use is limited to less than 5% of procedure. We have developed a new technique called the instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its accurate assessment. It has been approved for use in this indication. This study aims to compare clinical outcomes of patients whose treatment has been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as FFR its adoption will permit the clear benefits of this approach of identifying the coronary narrowings that really need treatment to be applicable to a much larger patient population and further improve healthcare costs.

対象疾患

Coronary Artery Disease

介入

iFR(DEVICE)
FFR(DEVICE)

依頼者(Sponsor)

実施施設 (5)

高島小児科医院

Aichi, Japan

Hiroyoshi Yokoi

Fukuoka, Japan

Yuetsu Kikuta

Fukuyama, Japan

田中医院

Tokyo, Japan

Hitosh Matsuo

Gifu, Japan