Percutaneous Coronary Intervention (PCI)IVUSNCT06974760
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
A study testing IVUS in people with Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease, run by Pulse Medical Imaging Technology (Shanghai) Co., Ltd at 4 sites in China.
Trial summary
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） Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease
- What is being tested?
- IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesChina
- Study dates
- 20 Jul 2023to 17 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital. Capital Medical University
Beijing
The Sixth Medical Center of PLA General Hospital
Beijing
Shanghai Tongji Hospital
Shanghai
Shanghai Zhongshan Hospital
Shanghai
About this study
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）
- Being tested
- IVUS
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUSDevice
The Participants will receive IVUS examinations from Pulse and Boston
| Study group | Role | What they receive |
|---|---|---|
| Boston IVUS | Other | Not described Receives: Device: IVUS |
| Pluse IVUS | Other | Not described Receives: Device: IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: From enrollment to the end of treatment at one week
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: estimated 1week on average, by opeartor's rating on questionaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 Jul 2023
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974760
- Sponsor's protocol ID
- BD-IVUS-002
- Acronym
- IVUS
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
- ClinicalTrials.gov ID
- NCT06974760
- Acronym / sponsor ID
- IVUS / BD-IVUS-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boston IVUS | Other | Device: IVUS |
| Pluse IVUS | Other | Device: IVUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUSThe Participants will receive IVUS examinations from Pulse and Boston | Device | Boston IVUS, Pluse IVUS |
Primary outcome
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 .
6 secondary outcomes
Minimal Lumen Area in square millimeter(MLA)
Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Stent Length in millimeter (SL)
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
Time frame: Estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Identification plaque properties
Time frame: 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
Maneuvering performance of catheter(questionnaire)
Time frame: estimated 1week on average, by opeartor's rating on questionaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS in people with Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease, run by Pulse Medical Imaging Technology (Shanghai) Co., Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: From enrollment to the end of treatment at one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.