Health TrialsbyHealthPanel

Coronary Aspiration Catheter Clinical Trial

ConditionST-segment Elevation Myocardial Infarction (STEMI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrosMed Medical Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspiration Catheter

    Device

    Thrombus aspiration using Aspiration Catheter

  • Export Advance Aspiration Catheter

    Device

    Thrombus aspiration using Export Advance Aspiration Catheter

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrosMed Medical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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