Physiologic Assessment of Coronary Stenosis Following PCI - DEFINE PCI

Philips Volcano0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1.Subject must be > 18 years old
•2.Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (unstable angina or biomarker positive)
•3.Single vessel CAD with at least 2 separate lesions (*10 mm apart) of *40% stenosis or a single long lesion of *20mm OR multi-vessel CAD, defined as at least 2 vessels with *40% stenosis
•4.Pre-PCI iFR performed in all vessels intended for PCI
•5.Pre-PCI iFR of <0.90 of at least 1 stenosis
•6.Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

•1.Pregnant or planning to become pregnant for the duration of the study
•2.Acute STEMI within the past 7 days
•3.Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
•4.Ionotropic or temporary pacing requirement
•5.Sustained ventricular arrhythmias
•6.Prior CABG
•7.Known ejection fraction *30%
•8.Chronic Total Occlusion (CTO)
•9.Known severe mitral or aortic stenosis.
•10.Any known medical comorbidity resulting in life expectancy < 12 months.
•11.Participation in any investigational study that has not yet reached its primary endpoint.
•12.Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
•13.TIMI flow <3 at baseline
•14.Intra-coronary thrombus on baseline angiography

发起方

Philips Volcano