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The Investigators will test the hypothesis that MGuard net protective stent, the investigational device, would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent percutaneous coronary interventions.
Embolization of thrombotic debris still represents a complication for ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary interventions (PCI).
Distal embolization may decrease coronary and myocardial reperfusion after PCI in STEMI setting.
Unfortunately, intracoronary filters present several important limitations limiting their use and their efficacy especially in presence of huge amount of thrombus. In this respect, recent trials investigated whether a default manual thrombectomy strategy before stenting would ameliorate angiographic as well as clinical outcomes for STEMI patients undergoing percutaneous revascularization.
Of note, the most of embolization occurs when guidewire, and thrombectomy device cross the thrombus, and after the stent has been implanted as a consequence of plaque prolapse through the stent struts.
MGuard net protective stent, the investigational device, is a bare-metal stent covered with a ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, that is anchored to the external surface of the struts. This biocompatible fiber net (string diameter 10-22 μm) has minimal effects on the stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net and isolating the prothrombotic intima components from the blood stream.
This protocol will test the hypothesis that MGuard stent would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent PCI in terms of angiographic as well as clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGuard | Experimental | MGuard net protective stent, investigational device |
|
| BMS plus thrombectomy | Active Comparator | Bare-metal stent plus manual thrombectomy device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGuard net protective coronary stent | Device | It is a new closed-cell design stent concept. with an ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, anchored to the external surface of the struts. This net (string diameter 10-22 μm) minimally affects stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Myocardial Perfusional Blush Grade 2-3 | Myocardial Perfusional Blush Grade 2-3 at the end of the procedure | 30 minutes after revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MACE | Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure. | 1 month |
| Complete ST-segment resolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Piscione, Associate Professor | Federico II University of Naples | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University of Naples | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19937780 | Background | Piscione F, Danzi GB, Cassese S, Esposito G, Cirillo P, Galasso G, Rapacciuolo A, Leosco D, Briguori C, Varbella F, Tuccillo B, Chiariello M. Multicentre experience with MGuard net protective stent in ST-elevation myocardial infarction: safety, feasibility, and impact on myocardial reperfusion. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):715-21. doi: 10.1002/ccd.22292. | |
| 20093945 |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| Bare-metal stent and manual thrombectomy device | Device | Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent |
|
Complete (>70%) ST-segment resolution at 60 minutes post-revascularization
| 60 minutes after revascularization |
| Thrombolysis in myocardial infarction antegrade coronary flow | TIMI coronary flow at the end of the procedure | 30 minutes after revascularization |
| Corrected TIMI Frame count | Corrected TIMI Frame count at the end of the procedure | 30 minutes after revascularization |
| Infarct related area reduction and left ventricular ejection fraction recovery | Six-month infarct related area reduction and left ventricular ejection fraction recovery as compared with infarct related area and and left ventricular ejection fraction at admission. | 6 months |
| Procedural device performance | Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability | 60 minutes after revascularizationl |
| Number of MACE | Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure. | 6 months |
| Number of MACE | Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure. | 12 months |
| Background |
| Rapacciuolo A, D'andrea C, Maresca G, di Pietro E, Piscione F, Chiariello M. Multiple MGuard stent implantation to treat massive right coronary artery dissection during primary coronary angioplasty. J Cardiovasc Med (Hagerstown). 2011 May;12(5):356-60. doi: 10.2459/JCM.0b013e328334092d. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D016769 | Embolism and Thrombosis |