Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System (NEW-IVUS)

Insight Lifetech

Status: Completed

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Left Main Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery

Treatments: Device: Insight Lifetech IVUS System; Device: Boston Scientific IVUS System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04739657

CTP-02-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 Years and older;
• Understand and willing to sign the informed consent form;
• Clinical evaluation shows that the coronary artery stent implantation and the intravascular ultrasound(IVUS) guidance is required.

Exclusion criteria

• Unable to understand or unwilling to sign the informed consent form;
• Clinically diagnosed with severe coronary artery spasms;
• Contraindicated to percutaneous coronary intervention (PCI);
• Presence of any other factor that the investigator deems is unsuitable for enrollment or completion of this study.

Trial design

130 participants in 1 patient group

Participants

Description:

Subjects whose clinical conditions require stent implantation, and the interventional procedure of which needs the guidance of IVUS imaging.

Treatment:

Device: Boston Scientific IVUS System

Device: Insight Lifetech IVUS System