MGuard Stent in ST-elevation Myocardial Infarction (GUARDIAN)

• Number of patients with Myocardial Perfusional Blush Grade 2-3 [ Time Frame: 30 minutes after revascularization ] [ Designated as safety issue: No ]
  Myocardial Perfusional Blush Grade 2-3 at the end of the procedure
  
  

• Number of MACE [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
  
  
• Complete ST-segment resolution [ Time Frame: 60 minutes after revascularization ] [ Designated as safety issue: No ]
  Complete (>70%) ST-segment resolution at 60 minutes post-revascularization
  
  
• Thrombolysis in myocardial infarction antegrade coronary flow [ Time Frame: 30 minutes after revascularization ] [ Designated as safety issue: No ]
  TIMI coronary flow at the end of the procedure
  
  
• Corrected TIMI Frame count [ Time Frame: 30 minutes after revascularization ] [ Designated as safety issue: No ]
  Corrected TIMI Frame count at the end of the procedure
  
  
• Infarct related area reduction and left ventricular ejection fraction recovery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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.
  
  
• Procedural device performance [ Time Frame: 60 minutes after revascularizationl ] [ Designated as safety issue: No ]
  Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability
  
  
• Number of MACE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
  
  
• Number of MACE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
  
  

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.