Coronary Artery DiseaseNCT06345209
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels
A study testing Sirolimus-coated Coronary Balloon Dilatation Catheter and Drug-coated Coronary Balloon Dilatation Catheter in people with Coronary Artery Disease, run by BrosMed Medical Co., Ltd.
Trial summary
To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sirolimus-coated Coronary Balloon Dilatation Catheter and Drug-coated Coronary Balloon Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 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
- Age ≥18 years old, gender is not limited
- Diagnosed with stable or unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia
- Suitable for balloon angioplasty
- Be able to understand the purpose of the trial, be willing to cooperate in the follow-up, and voluntarily sign an informed consent form.
- Primary coronary small vessel lesions with a visual lesion length of ≤36mm and a visual lesion diameter of ≥2.00mm and ≤2.75mm
- Target lesions with ≥70% or ≥50% diameter stenosis with evidence of ischemia before interventional therapy
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- Residual stenosis of ≤30% visualized after pre-interventional dilatation of the target lesion without type C or higher entrapment
- In the presence of multiple lesions requiring treatment, one of the lesions that meets the requirements should be selected as the target lesion, and the non-target lesion should be in a different vascular branch from the target lesion.
- Patients with at most two non-target lesions requiring simultaneous treatment, and the non-target lesion should undergo interventional therapy before the target lesion, and there are no serious complications after treatment.
Who cannot join
- Patients who had a myocardial infarction within 7 days before enrollment (2) Patients with cardiogenic shock (3) Patients with renal insufficiency (eGFR < 30 ml/min) or vital organ failure (4) Patients with known allergy or intolerance to contrast media or to rapamycin, paclitaxel and/or their analogs (5) Patients with hematologic disorders, or contraindications to anticoagulant/antiplatelet agents, or intolerance to aspirin or clopidogrel (6) Patients with severe valvular heart disease or who have undergone heart transplantation (7) Patients who are not suitable for coronary artery bypass graft surgery (CABG) (8) Patients with congestive heart failure or NYHA class IV (9) Patients who have had a stroke within 6 months prior to enrollment, or have a history of gastrointestinal bleeding or active gastric ulcers, or who have been determined by the investigator to have a bleeding constitution (10) Patients with a life expectancy of less than 1 year (11) Pregnant or lactating females (12) Patients who are participating in clinical trials of other drugs or medical devices (13) Patients who, in the opinion of the investigator, are not suitable for enrollment for other reasons.
- Totally occluded (TIMI grade 0) lesions (15) Presence of coronary artery spasm without significant stenosis (16) Unprotected left main stem lesions (17) Patients with a bifurcation lesion (branch diameter ≥2.00 mm) as the target lesion (18) Patients with target lesions that are severely tortuous (preventing smooth catheter passage) or severely calcified (19) Patients with secondary stenosis caused by pre-dilatation of the target lesion (20) Patients with a well-defined thrombus in the target vessel
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter for the Treatment of De Novo Coronary Artery Small Vessel Lesions.
To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries.
- Conditions
- Coronary Artery Disease
- Being tested
- Sirolimus-coated Coronary Balloon Dilatation Catheter, Drug-coated Coronary Balloon Dilatation Catheter
- 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.
Sirolimus-coated Coronary Balloon Dilatation CatheterDevice
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
Drug-coated Coronary Balloon Dilatation CatheterDevice
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Drug-coated Coronary Balloon Dilatation Catheter in the test 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 Coronary Balloon Dilatation Catheter |
| Control Group | Active comparator | Drug Eluting Balloon Catheter Receives: Device: Drug-coated Coronary Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss (LLL)
Late luminal loss (LLL) within the target lesion segment at 9 months postoperatively
Measured: 9 months after procedure
Secondary outcomes (1)
Device success rate
Successful delivery and dilatation of the drug-coating balloon catheter across lesion, and target lesion residual stenosis≤30% (visual inspection) without additional interventional treatment.
Measured: Immediately after PTCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345209
- Sponsor's protocol ID
- BM-D19
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter for the Treatment of De Novo Coronary Artery Small Vessel Lesions.
- ClinicalTrials.gov ID
- NCT06345209
- Acronym / sponsor ID
- BM-D19
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Apr 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.
To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries.
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 Coronary Balloon Dilatation CatheterSirolimus-coated Coronary Balloon Dilatation Catheter |
| Control Group | Active comparator | Device: Drug-coated Coronary Balloon Dilatation CatheterDrug Eluting Balloon Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years old, gender is not limited
- Diagnosed with stable or unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia
- Suitable for balloon angioplasty
- Be able to understand the purpose of the trial, be willing to cooperate in the follow-up, and voluntarily sign an informed consent form.
- Primary coronary small vessel lesions with a visual lesion length of ≤36mm and a visual lesion diameter of ≥2.00mm and ≤2.75mm
Key exclusion criteria (2 listed)
- Patients who had a myocardial infarction within 7 days before enrollment (2) Patients with cardiogenic shock (3) Patients with renal insufficiency (eGFR < 30 ml/min) or vital organ failure (4) Patients with known allergy or intolerance to contrast media or to rapamycin, paclitaxel and/or their analogs (5) Patients with hematologic disorders, or contraindications to anticoagulant/antiplatelet agents, or intolerance to aspirin or clopidogrel (6) Patients with severe valvular heart disease or who have undergone heart transplantation (7) Patients who are not suitable for coronary artery bypass graft surgery (CABG) (8) Patients with congestive heart failure or NYHA class IV (9) Patients who have had a stroke within 6 months prior to enrollment, or have a history of gastrointestinal bleeding or active gastric ulcers, or who have been determined by the investigator to have a bleeding constitution (10) Patients with a life expectancy of less than 1 year (11) Pregnant or lactating females (12) Patients who are participating in clinical trials of other drugs or medical devices (13) Patients who, in the opinion of the investigator, are not suitable for enrollment for other reasons.
- Totally occluded (TIMI grade 0) lesions (15) Presence of coronary artery spasm without significant stenosis (16) Unprotected left main stem lesions (17) Patients with a bifurcation lesion (branch diameter ≥2.00 mm) as the target lesion (18) Patients with target lesions that are severely tortuous (preventing smooth catheter passage) or severely calcified (19) Patients with secondary stenosis caused by pre-dilatation of the target lesion (20) Patients with a well-defined thrombus in the target vessel
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 Coronary Balloon Dilatation CatheterDuring PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure | Device | Test Group |
| Drug-coated Coronary Balloon Dilatation CatheterDuring PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Drug-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure | Device | Control Group |
Primary outcome
Late luminal loss (LLL)
Time frame: 9 months after procedure
Late luminal loss (LLL) within the target lesion segment at 9 months postoperatively
1 secondary outcome
Device success rate
Time frame: Immediately after PTCA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus-coated Coronary Balloon Dilatation Catheter and Drug-coated Coronary Balloon Dilatation Catheter in people with Coronary Artery Disease, run by BrosMed Medical Co., Ltd.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Late luminal loss (LLL) (time frame: 9 months after procedure). 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 3 Apr 2024.