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200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1) rate of complete ST-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) at 3 months after the index procedure.
Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard primary coronary intervention | Active Comparator |
| |
| coronary thrombectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary thrombectomy | Device | coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure | 60 minutes after the end of the procedure | |
| Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI) | 3 months after the index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23257370 | Derived | De Carlo M, Aquaro GD, Palmieri C, Guerra E, Misuraca L, Giannini C, Lombardi M, Berti S, Petronio AS. A prospective randomized trial of thrombectomy versus no thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) trial. JACC Cardiovasc Interv. 2012 Dec;5(12):1223-30. doi: 10.1016/j.jcin.2012.08.013. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Primary Coronary Intervention | standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices |
| FG001 | Coronary Thrombectomy | coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Primary Coronary Intervention | standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices |
| BG001 | Coronary Thrombectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure | Posted | Count of Participants | Participants | 60 minutes after the end of the procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Primary Coronary Intervention | standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco De Carlo, MD, PHD | Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, | +39 050995326 | marcodecarlo@gmail.com |
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| standard primary PCI (with stenting, as required) | Device | standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices |
|
coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| coronary TIMI frame count | Mean | Standard Deviation | frames |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI) | Posted | Mean | Standard Deviation | % of LV mass | 3 months after the index procedure |
|
|
|
| 2 |
| 104 |
| 0 |
| 104 |
| 0 |
| 104 |
| EG001 | Coronary Thrombectomy | coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration) | 2 | 104 | 0 | 104 | 0 | 104 |
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