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

Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System: A Multi-center Prospective Control Study

Sponsors

Lead Sponsor: Insight Lifetech Co., Ltd.

Collaborator: Shanghai Zhongshan Hospital
Guangdong Provincial People's Hospital
Chinese PLA General Hospital
Zhongda Hospital
The First Affiliated Hospital of Zhengzhou University
Shanghai 10th People's Hospital

Source Insight Lifetech Co., Ltd.
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 providing clear images of plague morphology, as well as the quantitative and qualitative assessment of coronary artery. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) measured by the two different IVUS diagnostic system.

Detailed 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) 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.

Overall Status Completed
Start Date 2021-03-01
Completion Date 2021-04-27
Primary Completion Date 2021-04-27
Study Type Observational
Primary Outcome
Measure Time Frame
Mean Stent Area in square millimeter(MSA) through the third-party IVUS image post-processing system analysis , an average of 1 month
Secondary Outcome
Measure Time Frame
Clear Stent Length in millimeter (CSL) through the third-party IVUS image post-processing system analysis , an average of 1 month
Minimal Lumen Area in square millimeter(MLA) through the third-party IVUS image post-processing system analysis , an average of 1 month
Detection rate of poor adherence, tissue prolapse and intercalation through the third-party IVUS image post-processing system analysis , an average of 1 month
Stability of system host questionnaire through the doctors' evaluation, an average of 1week
Trackability of catheter questionnaire through the doctors' evaluation, an average of 1week
Device success rate through intraoperative monitoring, an average of 1day
Rate of device-related adverse effects through intraoperative monitoring, an average of 1day
Enrollment 125
Condition
Intervention

Intervention Type: Device

Intervention Name: InSight Lifetech IVUS System

Description: The InSight Lifetech IVUS System is intended for examination of coronary intravascular pathology only, including TrueVisionTM intravascular ultrasound diagnostic catheter and VivoHeartTM intravascular ultrasound diagnostic device. Intravascular ultrasound imaging is used in patients who will undergo transluminal coronary intervention.

Arm Group Label: Participants

Other Name: IVUS diagnostic system

Intervention Type: Device

Intervention Name: Boston Scientific IVUS System

Description: The Boston Scientific IVUS System is intended for examination of coronary intravascular pathology only, including OpticrossTM coronary ultrasonic imaging catheter and iLABTM intravascular ultrasound diagnostic device. Intravascular ultrasound imaging is used in patients who will undergo transluminal coronary intervention.

Arm Group Label: Participants

Other Name: IVUS diagnostic system

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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; - Contraindications for percutaneous coronary intervention (PCI); - Presence of any other factor that the investigator deems is unsuitable for enrollment or completion of this study.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility:
The General Hospital of the People's Liberation Army | Beijing, China
Guangdong Provincial People's Hospital | Guangzhou, China
Zhongda Hospital of Southeast University | Nanjing, China
Shanghai Tenth People's Hospital | Shanghai, China
Shanghai Zhongshan Hospital | Shanhai, China
The First Affiliated Hospital of Zhengzhou University | Zhengzhou, China
Location Countries

China

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Participants

Description: Subjects who meet the inclusion criteria and do not meet the exclusion criteria and undergo IVUS measurement with the TrueVisionTM intravascular ultrasound diagnostic catheter and the OptiCrossTM coronary ultrasonic imaging catheter.

Acronym NEW-IVUS
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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