Coronary Arterial Disease (CAD)NCT06822712
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
A study testing Sirolimus-coated Balloon Dilatation Catheter and Paclitaxel-coated Balloon Dilatation Catheter in people with Coronary Arterial Disease (CAD), run by BrosMed Medical Co., Ltd at 1 site in China.
Trial summary
Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Sirolimus-coated Balloon Dilatation Catheter and Paclitaxel-coated Balloon Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to Jun 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in this clinical trial must meet all of the following criteria:
- General Inclusion Criteria
- Age ≥18 years and ≤80 years.
- Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable.
- Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG).
- Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent document by signing the informed consent form, and willing to undergo invasive imaging follow-up.
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- Angiographic Inclusion Criteria
- A maximum of 2 vessels requiring treatment, with no more than 3 lesions in total.
- If the non-target lesion and the target lesion are in the same vessel, the non-target lesion must be located distal to the target lesion.
- Successful interventional treatment of the non-target lesion prior to the target lesion.
- Only one true bifurcation lesion requiring treatment (Medina classification 1.1.1, 1.0.1, 0.1.1), with a diameter stenosis ≥70% (by visual estimation) at the ostium of the target lesion side branch.
- Successful pre-dilation/kissing balloon of the target lesion side branch, no dissection grade C or higher, residual stenosis ≤30% (by visual estimation) in the side branch lesion, and TIMI 3 flow.
- Suitable for PCI, with the main branch lesion of the target lesion planned for stent implantation without drug-coated balloon treatment, and the side branch lesion treated with a drug-coated balloon without stent implantation; it is recommended to perform kissing balloon dilation for both the main and side branches.
- Reference diameter of the target lesion side branch 2.0-4.0 mm, and lesion length ≤38 mm.
Who cannot join
- If a participant has any of the following conditions, they will be excluded from the study:
- General Exclusion Criteria
- Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.
- Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).
- Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.
- Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy.
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- History of Peptic Ulcer or Gastrointestinal Bleeding within the Past 6 Months: Or history of cerebral hemorrhage, cerebral infarction, or other cerebrovascular accidents (stroke) within the past 6 months.
- Known Allergies to Contrast Agents, Paclitaxel, Sirolimus, or Their Derivatives.
- Life Expectancy Less Than 12 Months.
- Poor Compliance: Participants who, in the investigator's judgment, are unlikely to adhere to the study requirements or are otherwise deemed unsuitable for inclusion.
- Participation in Other Ongoing Clinical Trials: Participants who have not reached the primary endpoint in other ongoing clinical trials.
- Pregnant or Lactating Women: Women who plan to conceive within 12 months or are unwilling to use effective contraception.
- Angiographic Exclusion Criteria
- Left Main Trunk and Its Bifurcation Lesions Requiring Treatment.
- Thrombus in the Target Lesion: Excessive tortuosity of the vessel, making it unlikely for the balloon to pass through the lesion.
- Total Occlusion in the Side Branch Lesion of the Target Lesion.
- Severe Calcification in the Side Branch Lesion of the Target Lesion: Lesions that cannot be pre-dilated or treated with double-balloon kissing dilation.
- In-Stent Restenosis in the Target Vessel (Including Both Main and Side Branches).
- Residual Stenosis >30% (by Visual Estimation) or Dissection Grade C or Higher After Pre-Dilation or Double-Balloon Kissing Dilation of the Side Branch Lesion of the Target Lesion.
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 Hospital of Lanzhou University
Lanzhou, Gansu
Bai Ming, 0931-8619797, baiming@vip.163.com
About this study
Official title: A Prospective, Multicenter, Noninferiority, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated Balloon Catheter for the Treatment of De Novo Coronary Bifurcation Lesions
Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Sirolimus-coated Balloon Dilatation Catheter, Paclitaxel-coated Balloon Dilatation Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-coated Balloon Dilatation CatheterDevice
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
Paclitaxel-coated Balloon Dilatation CatheterDevice
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Paclitaxel-coated Balloon Dilatation Catheter in the control group, subsequently completing the remaining procedure
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Sirolimus-coated Coronary Balloon Dilatation Catheter Receives: Device: Sirolimus-coated Balloon Dilatation Catheter |
| Control Group | Active comparator | Paclitaxel-coated Balloon Catheter (Brand: Bingo®) Receives: Device: Paclitaxel-coated Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of stenosis
Degree of stenosis (%) of target bifurcation lesion segment diameter at 9 months postoperatively (Measured by QCA)
Measured: 9 Months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start3 Mar 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LanZhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822712
- Sponsor's protocol ID
- BM-D19-2
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Noninferiority, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated Balloon Catheter for the Treatment of De Novo Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT06822712
- Acronym / sponsor ID
- BM-D19-2
- Conditions
- Coronary Arterial Disease (CAD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- LanZhou University
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Feb 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.
Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Sirolimus-coated Balloon Dilatation CatheterSirolimus-coated Coronary Balloon Dilatation Catheter |
| Control Group | Active comparator | Device: Paclitaxel-coated Balloon Dilatation CatheterPaclitaxel-coated Balloon Catheter (Brand: Bingo®) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- General Inclusion Criteria
- Age ≥18 years and ≤80 years.
- Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable.
- Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG).
- Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent document by signing the informed consent form, and willing to undergo invasive imaging follow-up.
Key exclusion criteria (19 listed)
- If a participant has any of the following conditions, they will be excluded from the study:
- General Exclusion Criteria
- Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.
- Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).
- Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.
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 |
|---|---|---|
| Sirolimus-coated Balloon Dilatation CatheterDuring PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure | Device | Test Group |
| Paclitaxel-coated Balloon Dilatation CatheterDuring PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Paclitaxel-coated Balloon Dilatation Catheter in the control group, subsequently completing the remaining procedure | Device | Control Group |
Primary outcome
Degree of stenosis
Time frame: 9 Months postoperatively
Degree of stenosis (%) of target bifurcation lesion segment diameter at 9 months postoperatively (Measured by QCA)
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 17 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus-coated Balloon Dilatation Catheter and Paclitaxel-coated Balloon Dilatation Catheter in people with Coronary Arterial Disease (CAD), 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 14 inclusion and 19 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 17 Sep 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of stenosis (time frame: 9 Months postoperatively). 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 17 Sep 2025.