Coronary Artery Disease (CAD)NCT07742345
Clinical Study of Coronary Extension Catheter
A study testing Coronary Extension Catheter in people with Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by BrosMed Medical Co., Ltd at 1 site in China.
Trial summary
This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Coronary Extension Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2026to 30 Apr 2027
- 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, regardless of gender;
- Patients suitable for percutaneous coronary intervention (PCI) and for whom the use of an extension catheter is planned to assist the intervention;
- Ability to understand the purpose of the study, willingness to voluntarily participate, and ability to provide written informed consent.
Who cannot join
- Reference vessel diameter < 2 mm;
- Presence of thrombus in the target vessel;
- Unprotected left main coronary artery disease;
- Acute myocardial infarction occurring within 7 days prior to enrollment;
- Known intolerance to anticoagulant or antiplatelet therapy, or known allergy to contrast media;
- Concurrent severe hepatic or renal disease, or other severe systemic conditions that render the patient unsuitable for PCI;
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- Pregnant or lactating women;
- Currently participating in another clinical trial of a drug or medical device without having reached the primary endpoint or completed the trial;
- Any other condition that, in the investigator's opinion, makes the patient ineligible for participation in this study.
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
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Xiantao Song, PhD, 010-63139850, songxiantao0929@qq.com
About this study
Official title: A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.
- Being tested
- Coronary Extension Catheter
- Keywords
- Percutaneous Coronary Intervention (PCI)
- 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.
Coronary Extension CatheterDevice
For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Not described Receives: Device: Coronary Extension Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Delivery Success Rate
Device delivery success is defined as the successful delivery of the target device (balloon and/or stent) to the target lesion after the use of the study device during percutaneous coronary intervention (PCI).
Measured: Immediately after procedure, 0 day
Secondary outcomes (5)
Procedural Success Rate
Procedural success is defined as residual stenosis of the target lesion ≤30% (by visual estimation) and TIMI flow grade 3 after PCI.
Measured: Immediately after procedure, 0 day
Device Usage Evaluation
The device usage evaluation includes: pushability, support, overall ease of use, device trackability, and radiopacity. There are four grades, ranging from poor to excellent.
Measured: Immediately after procedure, 0 day
Adverse events and serious adverse events related to the study device
Adverse events and serious adverse events related to the study device during the study.
Measured: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Adverse Event and Serious Adverse Event
Occurrence of adverse events and serious adverse events during the study.
Measured: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Device defects
Incidence of device defects.
Measured: Immediately after procedure, 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start25 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT07742345
- Sponsor's protocol ID
- BM-D28
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07742345
- Acronym / sponsor ID
- BM-D28
- Keywords
- Percutaneous Coronary Intervention (PCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Aug 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 prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: Coronary Extension Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years, regardless of gender;
- Patients suitable for percutaneous coronary intervention (PCI) and for whom the use of an extension catheter is planned to assist the intervention;
- Ability to understand the purpose of the study, willingness to voluntarily participate, and ability to provide written informed consent.
Key exclusion criteria (9 listed)
- Reference vessel diameter < 2 mm;
- Presence of thrombus in the target vessel;
- Unprotected left main coronary artery disease;
- Acute myocardial infarction occurring within 7 days prior to enrollment;
- Known intolerance to anticoagulant or antiplatelet therapy, or known allergy to contrast media;
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 |
|---|---|---|
| Coronary Extension CatheterFor the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment. | Device | test group |
Primary outcome
Device Delivery Success Rate
Time frame: Immediately after procedure, 0 day
Device delivery success is defined as the successful delivery of the target device (balloon and/or stent) to the target lesion after the use of the study device during percutaneous coronary intervention (PCI).
5 secondary outcomes
Procedural Success Rate
Time frame: Immediately after procedure, 0 day
Device Usage Evaluation
Time frame: Immediately after procedure, 0 day
Adverse events and serious adverse events related to the study device
Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Adverse Event and Serious Adverse Event
Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Device defects
Time frame: Immediately after procedure, 0 day
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 3 Aug 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 Coronary Extension Catheter in people with Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), 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 3 inclusion and 9 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 3 Aug 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 Sone, PhD (010-63198850, songxiantao0929@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Delivery Success Rate (time frame: Immediately after procedure, 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 3 Aug 2026.