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To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Thrombus aspiration therapy using the test device |
|
| Control Group | Experimental | Thrombus aspiration therapy using the control device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspiration Catheter | Device | Thrombus aspiration using Aspiration Catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of TIMI flow grad 3 after PCI | Defined as the percentage of subjects with TIMI flow graded 3 after PCI. | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after procedure |
| MBG |
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Inclusion Criteria:
- General inclusion criteria
Exclusion Criteria:
- 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;
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ge Junpo, Ph.D | Contact | 021-31587851 | ge.junbo@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Export Advance Aspiration Catheter |
| Device |
Thrombus aspiration using Export Advance Aspiration Catheter |
|
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.
| 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. | 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. | Day 0 |
| Thrombus aspiration time and number of aspirations | Record and compare the total thrombus aspiration time and number of aspirations in both groups. | 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. | Immediately after procedure |
| MACE | MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR) | 30-day follow-up after procedure |
| AE and SAE | Incidence of all adverse events, serious adverse events in both groups | 30-day follow-up after procedure |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |