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RecruitingNCT06951724Updated Apr 30, 2025

Coronary Aspiration Catheter Clinical Trial

An interventional study of Aspiration Catheter and Export Advance Aspiration Catheter in ST-segment Elevation Myocardial Infarction (STEMI), sponsored by BrosMed Medical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by BrosMed Medical Co., Ltd · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).

02

Conditions studied

  • ST-segment Elevation Myocardial Infarction (STEMI)
03

In context

ST Elevation Myocardial Infarction

850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.

This study's planned enrollment of 144 is below the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

BrosMed Medical Co., Ltd is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Browse BrosMed Medical Co., Ltd studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • General inclusion criteria
  1. Age 18-80 years old (inclusive);
  2. 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 );
  3. Voluntary participation and signed written . Imaging Inclusion Criteria
  4. DSA image showed that the target lesion was in situ coronary artery lesion;
  5. Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;

Exclusion criteria

Exclusion Criteria:

  • General exclusion criteria
  1. previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
  2. Comorbid cardiogenic shock;
  3. severe renal failure or ongoing dialysis;
  4. severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
  5. Failure of preoperative thrombolysis requiring remedial PCI;
  6. Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
  7. Ischemic stroke within 3 months prior to surgery;
  8. Known allergy to anticoagulant and antiplatelet agents or contrast media;
  9. female subjects who are known to be pregnant or lactating;
  10. Participation or planned participation in other clinical studies of drugs or devices;

  11. other conditions that the investigator evaluates to be unsuitable for participation in this trial.

    Imaging exclusion criteria

  12. Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
  13. severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
  14. the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
  15. the presence of severe triple coronary artery lesions requiring revascularization.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Test Group

    Thrombus aspiration therapy using the test device

    Device: Aspiration Catheter

  • Experimental
    Control Group

    Thrombus aspiration therapy using the control device

    Device: Export Advance Aspiration Catheter

Interventions

  • DeviceAspiration Catheter

    Thrombus aspiration using Aspiration Catheter

  • DeviceExport Advance Aspiration Catheter

    Thrombus aspiration using Export Advance Aspiration Catheter

06

What researchers measure

Primary outcomes

  1. The rate of TIMI flow grad 3 after PCI

    Defined as the percentage of subjects with TIMI flow graded 3 after PCI.

    Time frame: Immediately after procedure

Secondary outcomes

  1. 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

    Time frame: Immediately after procedure

  2. 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.

    Time frame: Immediately after procedure

  3. 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.

    Time frame: Immediately after procedure

  4. 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.

    Time frame: Day 0

  5. Thrombus aspiration time and number of aspirations

    Record and compare the total thrombus aspiration time and number of aspirations in both groups.

    Time frame: Immediately after procedure

  6. 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.

    Time frame: Immediately after procedure

  7. MACE

    MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR)

    Time frame: 30-day follow-up after procedure

  8. AE and SAE

    Incidence of all adverse events, serious adverse events in both groups

    Time frame: 30-day follow-up after procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Feb 2026, 12 months after the start.

Of 143 interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2025
First posted
Apr 30, 2025
StartActual
Feb 20, 2025
Primary completionEst.
Feb 20, 2026
CompletionEst.
Jun 30, 2026
Last update
Apr 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06951724
Lead sponsor
BrosMed Medical Co., Ltd
Responsible party
Sponsor
First posted
Apr 30, 2025
Start date
Feb 20, 2025
Primary completion
Feb 20, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 30, 2025

Study contacts

Ge Junpo, Ph.D
Contact
ge.junbo@zs-hospital.sh.cn
021-31587851

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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