Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT04739657
Brief Summary:
Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology, providing quantitative and qualitative assessment of coronary arteries. Besides, IVUS has already an established role in guidance and optimization of percutaneous coronary intervention. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) results measured by the two different IVUS diagnostic systems.
Detailed Description:
Many studies have reported that IVUS is an accurate method for determining the size of the target vessel undergoing stent implantation , and the optimal stent deployment (complete stent expansion and apposition and lack of edge dissection or other complications after 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 includes TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic console. It is a novel device with high speed, high resolution, and high image acquisition rate enabling high-speed pullback imaging up to 10mm/sec.
This study is a prospective, multi-center, randomized, single-blind, controlled study with the primary target of investigating the differences, if any, between IVUS measurement results by the Insight Lifetech IVUS system and Boston Scientific IVUS system, imaging catheter of which was available at 40MHz during the study. Other purposes included analyzing the feasibility of the Insight Lifetech IVUS system's high-speed pullback during the IVUS assessment. A total of 130 patients will be recruited from 5 centers in China.
Study:
NCT04739657
Study Brief:
Protocol Section:
NCT04739657