Viewing Study NCT01444599



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Last Modification Date: 2024-10-26 @ 10:41 AM
Study NCT ID: NCT01444599
Status: COMPLETED
Last Update Posted: 2015-03-24
First Post: 2011-09-26

Brief Title: VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
Sponsor: Inje University
Organization: Inje University

Study Overview

Official Title: Virtual Histology VH-Intravascular Ultrasound IVUS Tissue Characteristics Analysis of the Intermediate Coronary Artery Stenosis Lesion Predicting Physiologic Myocardial Ischemia by Myocardial Fraction Flow Reserve FFR
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Recent clinical trials demonstrated that virtual histology-intravascular ultrasound VH-IVUS is a useful test predicting clinical outcomes of the coronary artery disease CAD Thin cap fibroatheroma VH-TCFA was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70 plaque burden and less than 4mm² minimal lumen area MLA by IVUS Fractional flow reserve FFR is an established index of the physiological significance of a coronary stenosis Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes VH-IVUS represents anatomical severity but FFR represents functional severity of CAD Few studies reported relevance between two tests Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None