Atherosclerotic PlaqueNCT06214754
Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI
A study testing PCI in people with Atherosclerotic Plaque, run by BrosMed Medical Co., Ltd at 12 sites in China.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerotic Plaque
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 12 sitesChina
- Study dates
- 16 Jun 2023to 28 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
- Be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study;
- Ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence [e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)；
- Investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion；
- The presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; Or ≥50% (visual) with evidence of ischemia, TIMI ≥ level 1；
- The patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment；
- The reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm；
- When there are multiple lesions that need to be treated, only one in situ coronary lesion is selected as the target lesion, and the non-target lesion must be located on different vascular branches；
Who cannot join
- Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
- Have had any myocardial infarction within a week；
- People who have an allergic reaction to contrast media or can't take medication
- There was severe renal failure with or without dialysis, glomerular filtration rate (eGFR) <30ml/min/1.73m2 or serum creatinine level >2.0 mg/ dl；
- cardiogenic shock；
- Patients who have received heart transplants；
Show all 18Show fewer
- Patients who are not eligible for coronary artery bypass surgery；
- The patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery；
- The patient had a stroke or transient ischemic attack within 2 months before surgery；
- Patients in the pregnancy or lactation period；
- Participants are currently participating in any other clinical trial within 1 month prior to the trial；
- Patients deemed unsuitable for inclusion by other investigators；
- Severe calcified lesions and twisted lesions or lesion sites > 45 degrees angled；
- Lesions with significant endometrial tears
- Unprotected left main lesion；
- The contrast showed a blood clot；
- Scaffold fracture lesion；
- Distal stent lesion after stent implantation；
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Hunan Provincial People's Hospital
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
Daqing Oilfield General Hospital
Daqing, Heilongjiang
the First Affiliated Hospital of USTC
Hefei, Anhui
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Neimenggu
China-Japan Union Hospital of Jilin University
Jilin City, Jilin
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
the second affiliated hospital of Nanchang university
Nanchang, Jiangxi
Renmin Hospital of Wuhan University
Wuhan, Hubei
First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial of the Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI
The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.
- Conditions
- Atherosclerotic Plaque
- Being tested
- PCI
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
The subjects underwent immediate coronary angiography after Percutaneous transluminal coronary angioplasty to evaluate the success rate of instruments, and immediate coronary angiography after PCI to evaluate the success rate of clinical treatment
| Study group | Role | What they receive |
|---|---|---|
| Intravascular high-pressure cutting balloon catheter | Active comparator | Not described Receives: Procedure: PCI |
| Boston Scientific Corporation | Active comparator | Not described Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Procedural Success Rate
In the case of balloon dilatation and stenosis, balloon delivery, balloon filling and dilatation, balloon withdrawal pressure retraction and successful balloon retraction can be successfully completed. After balloon dilatation, residual stenosis of the target lesion is less than 50%
Measured: immediately after PTCA
Secondary outcomes (1)
Clinical Success Rate
The residual lumen stenosis of the target lesion after surgery was less than 20%, the TIMI blood flow was grade 3, and there were no Major Adverse Cardiovascular Events during the follow-up period. MACE included cardiac death, myocardial infarction of the target vessel, or revascularization of the target lesion.
Measured: immediately after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 Jun 2023
- Primary completion22 Aug 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic PlaqueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214754
- Sponsor's protocol ID
- BM-839
- Status last verified
- Jun 2025
- First submitted
- 10 Jan 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial of the Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI
- ClinicalTrials.gov ID
- NCT06214754
- Acronym / sponsor ID
- BM-839
- Conditions
- Atherosclerotic Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 22 Jan 2024 (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 purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular high-pressure cutting balloon catheter | Active comparator | Procedure: PCI |
| Boston Scientific Corporation | Active comparator | Procedure: PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
- Be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study;
- Ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence [e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)；
- Investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion；
- The presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; Or ≥50% (visual) with evidence of ischemia, TIMI ≥ level 1；
Key exclusion criteria (18 listed)
- Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
- Have had any myocardial infarction within a week；
- People who have an allergic reaction to contrast media or can't take medication
- There was severe renal failure with or without dialysis, glomerular filtration rate (eGFR) <30ml/min/1.73m2 or serum creatinine level >2.0 mg/ dl；
- cardiogenic shock；
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 |
|---|---|---|
| PCIThe subjects underwent immediate coronary angiography after Percutaneous transluminal coronary angioplasty to evaluate the success rate of instruments, and immediate coronary angiography after PCI to evaluate the success rate of clinical treatment | Procedure or surgery | Boston Scientific Corporation, Intravascular high-pressure cutting balloon catheter |
Primary outcome
Device Procedural Success Rate
Time frame: immediately after PTCA
In the case of balloon dilatation and stenosis, balloon delivery, balloon filling and dilatation, balloon withdrawal pressure retraction and successful balloon retraction can be successfully completed. After balloon dilatation, residual stenosis of the target lesion is less than 50%
1 secondary outcome
Clinical Success Rate
Time frame: immediately after PCI
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 6 Jun 2025.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with Atherosclerotic Plaque, run by BrosMed Medical Co., Ltd at 12 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 8 inclusion and 18 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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Device Procedural Success Rate (time frame: immediately after PTCA). 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 6 Jun 2025.