Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System
NEW-IVUS
1 other identifier
observational
130
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2021
CompletedMay 11, 2022
May 1, 2022
2 months
December 21, 2020
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Stent Area in square millimeter(MSA)
Comparison between the MSA measured by the Insight Lifetech Intravascular Ultrasound Diagnositic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson correlation analysis.
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Secondary Outcomes (9)
Clear Stent Length in millimeter (CSL)
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Minimal Lumen Area in square millimeter(MLA)
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
The rate of detected stent malapposition, tissue prolapse and dissection
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Stability of system (questionnaire)
estimated 1week on average, by opeartor's rating on questionaire
Maneuvering performance of catheter (questionnaire)
estimated 1week on average, by opeartor's rating on questionaire
- +4 more secondary outcomes
Study Arms (1)
Participants
Subjects whose clinical conditions require stent implantation, and the interventional procedure of which needs the guidance of IVUS imaging.
Interventions
The Insight Lifetech IVUS System is intended for examination of coronary intravascular pathology only, including TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention.
The Boston Scientific IVUS System is intended for the examination of coronary intravascular pathology only, including Opticross IVUS diagnostic catheter and iLAB IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insight Lifetech Co., Ltd.lead
- Shanghai Zhongshan Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
- Zhongda Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
Study Sites (5)
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 Zhongshan Hospital
Shanhai, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junbo Ge, MD, PhD
Zhongshan Hospital of Fudan Unviersity
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2020
First Posted
February 4, 2021
Study Start
March 1, 2021
Primary Completion
April 27, 2021
Study Completion
April 27, 2021
Last Updated
May 11, 2022
Record last verified: 2022-05