ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Brief summary
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
Interventions
DEVICEAspiration Catheter
Thrombus aspiration using Aspiration Catheter
DEVICEExport Advance Aspiration Catheter
Thrombus aspiration using Export Advance Aspiration Catheter
Sponsors
BrosMed Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 ECG); 3. Voluntary participation and signed written informed consent. 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
\- General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of TIMI flow grad 3 after PCI | Immediately after procedure | Defined as the percentage of subjects with TIMI flow graded 3 after PCI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MBG | Immediately after procedure | 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. |
| TIMI Thrombus Grade | Immediately after procedure | 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. |
| STR(ST-segment resolution) at 90 minutes | Day 0 | 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. |
| TIMI flow after PCI | Immediately after procedure | 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 |
| Device technical success rate | Immediately after procedure | 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. |
| MACE | 30-day follow-up after procedure | MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR) |
| AE and SAE | 30-day follow-up after procedure | Incidence of all adverse events, serious adverse events in both groups |
| Thrombus aspiration time and number of aspirations | Immediately after procedure | Record and compare the total thrombus aspiration time and number of aspirations in both groups. |
Countries
China
Contacts
Primary ContactGe Junpo, Ph.D
Outcome results
None listed