Clinical trial NCT04739657: Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System
Official title: Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System: A Multi-center Prospective Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Coronary Artery Disease
Chronic Total Occlusion of Coronary Artery
Left Main Coronary Artery Disease
Keywords: high-speed, high-resolution IVUS
Lead sponsor: Insight Lifetech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
name: Guangdong Provincial People's Hospital
name: Chinese PLA General Hospital
name: Zhongda Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2021-02-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease which needs the qualitative and quantitative assessment by IVUS mearsurement, for whom the IVUS guidance during pre- and post-PCI is required.

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.

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

Primary outcomes:
measure: Mean Stent Area in square millimeter(MSA)
timeFrame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Secondary outcomes:
measure: Clear Stent Length in millimeter (CSL)
timeFrame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: Minimal Lumen Area in square millimeter(MLA)
timeFrame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: The rate of detected stent malapposition, tissue prolapse and dissection
timeFrame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: Stability of system (questionnaire)
timeFrame: estimated 1week on average, by opeartor's rating on questionaire
measure: Maneuvering performance of catheter (questionnaire)
timeFrame: estimated 1week on average, by opeartor's rating on questionaire
measure: Device success rate
timeFrame: estimated 1day on average, by intraoperative monitoring
measure: Rate of device-related adverse effects
timeFrame: estimated 1day on average, by intraoperative monitoring
measure: Rate of thrombosis, diffuse lesion and re-stenosis as discerned by IVUS
timeFrame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
measure: Rate of plaque rupture and plaque properties as discerned by IVUS
timeFrame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Nanjing
country: China
facility: Zhongda Hospital of Southeast University
city: Shanhai
country: China
facility: Shanghai Zhongshan Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Zhongshan Hospital of Fudan Unviersity
name: Junbo Ge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li C, Yang J, Wang X, et al. CLINICAL VALIDATION OF A NEW INTRAVASCULAR ULTRASOUND SYSTEM: A COMPARATIVE ANALYSIS ON LENGTH MEASUREMENTS. J Am Coll Cardiol. 2022 Mar, 79 (9_Supplement) 827.