MGuard Stent in ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial

Conditions
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ST-elevation Myocardial Infarction, Thrombus, Stents

Intervention / Treatment
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* Device: MGuard net protective coronary stent
* Device: Bare-metal stent and manual thrombectomy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 18-year-old patients, willing to participate the study, after informed consent signature Female not pregnant or potentially child-bearing > 1 mV ST segment elevation in two or more contiguous leads Acute MI lasting more than 30 minutes and less than 12 hours De novo acute MI Infarct related artery reference vessel diameter >/= 2.5 mm Patient suitable for stenting according to vessel and lesion features Exclusion Criteria: Dual antiplatelet therapy contraindication Ischemic stroke less than 30 days or previous haemorrhagic stroke WBC count less than 1000 per mm3; Platelet count less than 50.000 per mm3 Life expectancy less than 1 year Cardiogenic shock at admission Previous stented infarct related artery Stent thrombosis as the responsible for current STEMI Inability to identify infarct related artery True bifurcation lesion, or lesion near a side branch with a reference vessel diameter >/= 2.5 mm that could be diseased after stenting procedure LBBB Definitive pacing (or ECG abnormalities precluding ST-segment resolution evaluation Participation other study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGuard<br>MGuard net protective stent, investigational device | Device: MGuard net protective coronary stent<br>* 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.<br>* Other names: MGuard net protective stent;|
| Active Comparator: BMS plus thrombectomy<br>Bare-metal stent plus manual thrombectomy device | Device: Bare-metal stent and manual thrombectomy device<br>* Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |