Skip to main content
OpenTrials
Completed

NCT Number: NCT06974760

A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures

The goal of this clinical trial is to evaluate the safety and efficacy of IVUS Console and IVUS Catheter in coronary intervention therapy

Participants will:

Undergo IVUS examinations from two different manufacturers（from Pulse and Boston Scientific）

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Percutaneous Coronary Intervention (PCI) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital. Capital Medical University, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged ≥ 18 years old;
  • Subjects who require coronary artery intravascular ultrasound (IVUS) guidance prior to stent implantation upon clinical judgment;
  • Subjects who are able to understand and willing to sign the informed consent form (ICF).

Exclusion criteria

  • Subjects who are not suitable for percutaneous coronary stent implantation;
  • Subjects who are diagnosed with coronary artery spasm;
  • Subjects with a history of allergy to contrast agents;
  • Subjects who are participating in other clinical trials and have not yet reached the primary endpoint;
  • Subjects who are deemed ineligible to be included in this trial by the investigator.

Treatment and study plan

IVUS

Device

The Participants will receive IVUS examinations from Pulse and Boston

Primary outcomes

  1. Effectiveness

    Time frame: From enrollment to the end of treatment at one week

    Measure the Mean Stent Area in square millimeter(MSA)

    Comparison between the MSA measured by the Pulse and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis .

Secondary outcomes

  1. 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 Pubmed Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, as assessed by Bland-Altman analysis and Pearson analysis.

  2. Stent Length in millimeter (SL)

    Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis

    Comparison between the SL measured by the Pubmed Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, as assessed by Bland-Altman analysis and Pearson analysis.

  3. 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.

  4. Identification plaque properties

    Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis

    Rates of lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems

  5. Stability of system(questionnaire)

    Time frame: estimated 1week on average, by opeartor's rating on questionaire

    Evaluate the stability, ease of use, and clarity of captured images of the both IVUS systems from all enrolled case. Each performance includes three options: excellent, good, and poor.

  6. 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 :the pushability，the crossability and the angiographic visibility，Each performance includes three options: excellent, good, and poor.

Other outcomes

  1. Rate of intraoperative adverse effects

    Time frame: From enrollment to the end of treatment at one weeks

    Rate of device-related adverse effects, for each system individually, and comparison between the two systems.

  2. Rate of successful use of instruments

    Time frame: From enrollment to the end of treatment at one weeks

    Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems

Sponsors and collaborators

Lead sponsor

Pulse Medical Imaging Technology (Shanghai) Co., Ltd

Industry

Registry information

Acronym: IVUS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.