Coronary Artery DiseaseNCT07835178
Post-Marketing Clinical Study of High-Pressure Cutting Balloon
A study testing High pressure cutting balloon and Non-cutting balloon in people with Coronary Artery Disease and Calcification, run by BrosMed Medical Co., Ltd at 1 site in China.
Trial summary
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Calcification
- What is being tested?
- High pressure cutting balloon and Non-cutting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years;
- Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
- Moderate-to-severe calcified lesions on coronary angiography;
- Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
- Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
- In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;
- Provision of written informed consent.
Who cannot join
- Life expectancy <1 year;
- Cardiogenic shock or hemodynamic instability;
- Left main coronary artery disease;
- Chronic total occlusion;
- Bifurcation lesions planned for a "two-stent strategy";
- Active bleeding;
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- Known history of allergy to contrast media or metals;
- Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
- New-onset stroke/transient ischemic attack within 6 months;
- Pregnant or lactating women;
- Left ventricular ejection fraction <25%, or NYHA functional class IV, or Killip class ≥2;
- Non-target vessel revascularization within 30 days before randomization with complications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Ning Guo, Professor, 85323473, hearthx@126.com
About this study
Official title: A Clinical Study of the High-Pressure Cutting Balloon for Interventional Treatment of Calcified Coronary Lesions
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.
- Conditions
- Coronary Artery Disease, Calcification
- Being tested
- High pressure cutting balloon, Non-cutting balloon
- Keywords
- Coronary artery disease, calcification lesion
- Medical subject headings
- Coronary Artery Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High pressure cutting balloonDevice
Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
Non-cutting balloonDevice
Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | In the test group, the lesion is prepared using a high-pressure cutting balloon prior to DES implantation. Receives: Device: High pressure cutting balloon |
| Control group | Experimental | In the control group, the lesion is prepared using a non-cutting balloon prior to DES implantation. Receives: Device: Non-cutting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation
IVUS-measured results obtained after stent implantation and prior to balloon post-dilation
Measured: procedure day (0 day)
Secondary outcomes (3)
Procedural success
Defined as successful stent implantation, residual stenosis ≤20%, absence of severe complications such as severe dissection, perforation, acute occlusion, no-reflow, and intraprocedural death, and TIMI 3 flow in the target vessel.
Measured: procedure day (0 day)
Strategy success
Defined as successful stent implantation, residual stenosis ≤20%, absence of severe complications such as severe dissection, perforation, acute occlusion, no-reflow, and intraprocedural death, and no need for alternative calcium modification devices (e.g., bailout rotational atherectomy, excimer laser coronary atherectomy, shockwave balloon).
Measured: procedure day (0 day)
Major adverse cardiac events (MACE)
Defined as a composite endpoint consisting of all-cause death, unplanned urgent target vessel revascularization, unplanned cardiac surgery, or spontaneous myocardial infarction.
Measured: the hospitalization period and 30-day after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 280 participants (estimated)
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
- NCT07835178
- Sponsor's protocol ID
- BM-R21
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the High-Pressure Cutting Balloon for Interventional Treatment of Calcified Coronary Lesions
- ClinicalTrials.gov ID
- NCT07835178
- Acronym / sponsor ID
- BM-R21
- Conditions
- Coronary Artery Disease, Calcification
- Keywords
- Coronary artery disease, calcification lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Sep 2026 (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.
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: High pressure cutting balloonIn the test group, the lesion is prepared using a high-pressure cutting balloon prior to DES implantation. |
| Control group | Experimental | Device: Non-cutting balloonIn the control group, the lesion is prepared using a non-cutting balloon prior to DES implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years;
- Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
- Moderate-to-severe calcified lesions on coronary angiography;
- Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
- Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
Key exclusion criteria (12 listed)
- Life expectancy <1 year;
- Cardiogenic shock or hemodynamic instability;
- Left main coronary artery disease;
- Chronic total occlusion;
- Bifurcation lesions planned for a "two-stent strategy";
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 |
|---|---|---|
| High pressure cutting balloonLesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure. | Device | Test group |
| Non-cutting balloonLesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure. | Device | Control group |
Primary outcome
Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation
Time frame: procedure day (0 day)
IVUS-measured results obtained after stent implantation and prior to balloon post-dilation
3 secondary outcomes
Procedural success
Time frame: procedure day (0 day)
Strategy success
Time frame: procedure day (0 day)
Major adverse cardiac events (MACE)
Time frame: the hospitalization period and 30-day after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High pressure cutting balloon and Non-cutting balloon in people with Coronary Artery Disease and Calcification, run by BrosMed Medical Co., Ltd at 1 site 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Guo, Professor (85323473, hearthx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation (time frame: procedure day (0 day)). 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 22 Sep 2026.