Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System

Summary

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Description

Many studies have reported that IVUS is an accurate method for determining optimal stent development (complete stent expansion and apposition and lack of edge dissection or other complications after implantation), and the size of the vessel undergoing stent implantation. The novel 60 megahertz(60MHz...

Many studies have reported that IVUS is an accurate method for determining optimal stent development (complete stent expansion and apposition and lack of edge dissection or other complications after implantation), and the size of the vessel undergoing stent implantation. The novel 60 megahertz(60MHz) high-definition IVUS has evolved as a next-generation IVUS imaging technology to provide higher image resolution than conventional 40 megahertz(40MHz) IVUS but with sufficient imaging depth preserved for the assessment of the entire vessel wall structure. InSight Lifetech IVUS system is a novel device with high-speed and high-resolution, including TrueVisionTM intravascular ultrasound diagnostic catheter and VivoHeartTM intravascular ultrasound diagnostic device, and its higher image acquisition rate also enables high-speed pullback imaging at up to 10mm/sec. This study is a prospective, multi-center, randomized, single-blind, controlled study with the purpose of the differences, if any, between IVUS measurement by the InSight Lifetech IVUS system and Boston Scientific IVUS system whose imaging catheter is conventional 40MHz. The secondary purpose is to analyze the feasibility of high-speed pullback in the assessment of IVUS. A total of 125 patients will be recruited at 6 centers in China.

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