ST-segment Elevation Myocardial Infarction (STEMI)NCT06951724
Coronary Aspiration Catheter Clinical Trial
A study testing Aspiration Catheter and Export Advance Aspiration Catheter in people with ST-segment Elevation Myocardial Infarction (STEMI), run by BrosMed Medical Co., Ltd at 1 site in China.
Trial summary
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Aspiration Catheter and Export Advance Aspiration Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 30 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
- General inclusion criteria
- Age 18-80 years old (inclusive);
- Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
- Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
- DSA image showed that the target lesion was in situ coronary artery lesion;
- Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;
Who cannot join
- General exclusion criteria
- previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
- Comorbid cardiogenic shock;
- severe renal failure or ongoing dialysis;
- severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
- Failure of preoperative thrombolysis requiring remedial PCI;
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- Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
- Ischemic stroke within 3 months prior to surgery;
- Known allergy to anticoagulant and antiplatelet agents or contrast media;
- female subjects who are known to be pregnant or lactating;
- Participation or planned participation in other clinical studies of drugs or devices;
- other conditions that the investigator evaluates to be unsuitable for participation in this trial.
- Imaging exclusion criteria
- Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
- severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
- the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
- the presence of severe triple coronary artery lesions requiring revascularization.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Ge Junbo, Ph.D, 021-31587871, ge.junbo@zs-hospital.sh.cn
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
- Being tested
- Aspiration Catheter, Export Advance Aspiration Catheter
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration CatheterDevice
Thrombus aspiration using Aspiration Catheter
Export Advance Aspiration CatheterDevice
Thrombus aspiration using Export Advance Aspiration Catheter
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Thrombus aspiration therapy using the test device Receives: Device: Aspiration Catheter |
| Control Group | Experimental | Thrombus aspiration therapy using the control device Receives: Device: Export Advance Aspiration Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of TIMI flow grad 3 after PCI
Defined as the percentage of subjects with TIMI flow graded 3 after PCI.
Measured: Immediately after procedure
Secondary outcomes (8)
TIMI flow after PCI
Target vessel TIMI (Thrombolysis In Myocardial Infarction) flow grad after PCI, after completion of of coronary thrombus using the test device or control device to complete thrombus aspiration
Measured: Immediately after procedure
MBG
MBG (Myocardial Blush Grade) after coronary thrombus aspiration using either the test device or the control device. There are 4 levels of MBG. Grades range from 0 and up to 3, with higher grades being better.
Measured: Immediately after procedure
TIMI Thrombus Grade
TIMI Thrombus Grade after coronary thrombus aspiration using either the test device or the control device. There are 6 levels of MBG. Grades range from 0 and up to 5, with higher grades being worse.
Measured: Immediately after procedure
STR(ST-segment resolution) at 90 minutes
The index of change in the highest level of ST-segment elevation relative to the highest level of preoperative ST-segment elevation was assessed on the basis of electrocardiographic at 90 min ± 30 min after PCI.
Measured: Day 0
Thrombus aspiration time and number of aspirations
Record and compare the total thrombus aspiration time and number of aspirations in both groups.
Measured: Immediately after procedure
Device technical success rate
The test device or control device is able to successfully pass through all target lesions, complete thrombus aspiration, and successfully withdraw without complications relate to the procedure during thrombus aspiration, and TIMI flow grade 3 in the immediately after PCI.
Measured: Immediately after procedure
MACE
MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR)
Measured: 30-day follow-up after procedure
AE and SAE
Incidence of all adverse events, serious adverse events in both groups
Measured: 30-day follow-up after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start20 Feb 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 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
- NCT06951724
- Sponsor's protocol ID
- D23
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- 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 30 Apr 2025. 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 Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)
- ClinicalTrials.gov ID
- NCT06951724
- Acronym / sponsor ID
- D23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Apr 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.
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Aspiration CatheterThrombus aspiration therapy using the test device |
| Control Group | Experimental | Device: Export Advance Aspiration CatheterThrombus aspiration therapy using the control device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- General inclusion criteria
- Age 18-80 years old (inclusive);
- Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
- Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
- DSA image showed that the target lesion was in situ coronary artery lesion;
Key exclusion criteria (17 listed)
- General exclusion criteria
- previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
- Comorbid cardiogenic shock;
- severe renal failure or ongoing dialysis;
- severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
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 |
|---|---|---|
| Aspiration CatheterThrombus aspiration using Aspiration Catheter | Device | Test Group |
| Export Advance Aspiration CatheterThrombus aspiration using Export Advance Aspiration Catheter | Device | Control Group |
Primary outcome
The rate of TIMI flow grad 3 after PCI
Time frame: Immediately after procedure
Defined as the percentage of subjects with TIMI flow graded 3 after PCI.
8 secondary outcomes
TIMI flow after PCI
Time frame: Immediately after procedure
MBG
Time frame: Immediately after procedure
TIMI Thrombus Grade
Time frame: Immediately after procedure
STR(ST-segment resolution) at 90 minutes
Time frame: Day 0
Thrombus aspiration time and number of aspirations
Time frame: Immediately after procedure
Device technical success rate
Time frame: Immediately after procedure
MACE
Time frame: 30-day follow-up after procedure
AE and SAE
Time frame: 30-day follow-up 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 30 Apr 2025.
- 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 Aspiration Catheter and Export Advance Aspiration Catheter in people with ST-segment Elevation Myocardial Infarction (STEMI), 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 6 inclusion and 17 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 30 Apr 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?
Contact Ge Junpo, Ph.D (021-31587851, ge.junbo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of TIMI flow grad 3 after PCI (time frame: Immediately 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 30 Apr 2025.