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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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.
Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent
Federico II University of Naples
Naples, Italy
Number of patients with Myocardial Perfusional Blush Grade 2-3
Myocardial Perfusional Blush Grade 2-3 at the end of the procedure
Time frame: 30 minutes after revascularization
Number of MACE
Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Time frame: 1 month
Complete ST-segment resolution
Complete (\>70%) ST-segment resolution at 60 minutes post-revascularization
Time frame: 60 minutes after revascularization
Thrombolysis in myocardial infarction antegrade coronary flow
TIMI coronary flow at the end of the procedure
Time frame: 30 minutes after revascularization
Corrected TIMI Frame count
Corrected TIMI Frame count at the end of the procedure
Time frame: 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.
Time frame: 6 months
Procedural device performance
Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability
Time frame: 60 minutes after revascularizationl
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Number of MACE
Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Time frame: 6 months
Number of MACE
Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Time frame: 12 months