An interventional study of IVUS in Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease, sponsored by Pulse Medical Imaging Technology (Shanghai) Co., Ltd. Completed at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Pulse Medical Imaging Technology (Shanghai) Co., Ltd · Not applicable, Interventional, and Diagnostic
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）
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 150 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Pulse Medical Imaging Technology (Shanghai) Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: IVUS
Device: IVUS
The Participants will receive IVUS examinations from Pulse and Boston
Effectiveness
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 .
Time frame: From enrollment to the end of treatment at one week
Minimal Lumen Area in square millimeter(MLA)
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.
Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Stent Length in millimeter (SL)
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.
Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
The rate of detected stent malapposition, tissue prolapse and dissection
Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems.
Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Identification plaque properties
Rates of lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems
Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Stability of system(questionnaire)
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.
Time frame: estimated 1week on average, by opeartor's rating on questionaire
Maneuvering performance of catheter(questionnaire)
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.
Time frame: estimated 1week on average, by opeartor's rating on questionaire
Rate of intraoperative adverse effects
Rate of device-related adverse effects, for each system individually, and comparison between the two systems.
Time frame: From enrollment to the end of treatment at one weeks
Rate of successful use of instruments
Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems
Time frame: From enrollment to the end of treatment at one weeks
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Pulse Medical Imaging Technology (Shanghai) Co., Ltd