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

May 5, 2022 updated by: Insight Lifetech Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • The General Hospital of the People's Liberation Army
      • Guangzhou, China
        • Guangdong Provincial People's Hospital
      • Nanjing, China
        • Zhongda Hospital of Southeast University
      • Shanhai, China
        • Shanghai Zhongshan Hospital
      • Zhengzhou, China
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants
Subjects whose clinical conditions require stent implantation, and the interventional procedure of which needs the guidance of IVUS imaging.
Device: Insight Lifetech IVUS System
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.
Other Names:
  • IVUS diagnostic system
Device: Boston Scientific IVUS System
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.
Other Names:
  • IVUS diagnostic system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Stent Area in square millimeter(MSA)
Time Frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clear Stent Length in millimeter (CSL)
Time Frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Comparison between the CSL measured by the Insight Lifetech Intravascular Ultrasound Diagnostic 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 analysis.
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Minimal Lumen Area in square millimeter(MLA)
Time Frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Comparison between the MLA measured by the Insight Lifetech Intravascular Ultrasound Diagnostic 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 analysis.
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
The rate of detected stent malapposition, tissue prolapse and dissection
Time Frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems.
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Stability of system (questionnaire)
Time Frame: estimated 1week on average, by opeartor's rating on questionaire

Evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures :

  1. the stability of IVUS examination ;
  2. the usability of system operation;
  3. the definition of images.

For each system in 1., 2., and 3., only one of the following five ratings is given:

  • very stable/convenient/clear images;
  • stable/convenient/clear images, inspection was unaffected;
  • slightly unstable/inconvenient/unclear images, inspection was unaffected;
  • unstable/inconvenient/unclear images, inspection was affected; (in the order of 1./2./3.)
  • N/A.

and is counted as 1 point for that particular rating. The distribution of the points in rating and how many points each rating individually owns are compared between the systems.
estimated 1week on average, by opeartor's rating on questionaire
Maneuvering performance of catheter (questionnaire)
Time Frame: estimated 1week on average, by opeartor's rating on questionaire

Evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures :

  1. the pushability
  2. the crossability
  3. the angiographic visibility

For each system in 1., 2., and 3., only one of the following five ratings is given:

  • excellent pushability/lesion crossability/visibility;
  • pushing met slight resistance/crossed lesion smoothly/good visibility, inspection was unaffected;
  • pushing met obvious resistance/crossed lesion after attempts/mediocre visibility, inspection was unaffected;
  • too resistant to push/unable to cross lesion/very poor visibility, inspection was affected; (in the order of 1./2./3.)
  • N/A.

and is counted as 1 point for that particular rating. The distribution of the points in rating and how many points each rating individually owns are compared between the systems.
estimated 1week on average, by opeartor's rating on questionaire
Device success rate
Time Frame: estimated 1day on average, by intraoperative monitoring
Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems.
estimated 1day on average, by intraoperative monitoring
Rate of device-related adverse effects
Time Frame: estimated 1day on average, by intraoperative monitoring
Rate of device-related adverse effects, for each system individually, and comparison between the two systems.
estimated 1day on average, by intraoperative monitoring
Rate of thrombosis, diffuse lesion and re-stenosis as discerned by IVUS
Time Frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Rate of thrombosis, diffuse lesion and re-stenosis discerned by each system individually, and comparison between the two systems.
estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Rate of plaque rupture and plaque properties as discerned by IVUS
Time Frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Rates of plaque rupture, lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems.
estimated 1 month on average, by a third-party corelab IVUS image post-analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insight Lifetech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Zhongshan Hospital
Chinese PLA General Hospital
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Zhongda Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junbo Ge, MD, PhD, Zhongshan Hospital of Fudan Unviersity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP-02-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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