Safety and Efficacy Study of MGuard Stent After a Heart Attack

Study Overview
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Brief Summary
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The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).

Official Title
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MASTER: MGUARD for Acute ST Elevation Reperfusion

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: MGuard
* Device: Control BMS or DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18 years of age ST-segment elevation (more than 2mm in more than contiguous leads) MI with symptom onset less than 12h The patient is willing to comply with specified follow-up evaluations Signed ICF Single de novo lesion in the target (culprit) vessel Target lesion maximum length is 33 mm (by visual estimation) Reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation Randomization should occur as soon as Presence of TIMI 2 or 3 before randomization Exclusion Criteria Pregnant or nursing patients Left Bundle Branch Block (LBBB), paced rhythm, or other Electrocardiogram (ECG) abnormality Impaired renal function Prior coronary artery bypass graft surgery Bleeding diathesis Contraindication to aspirin cardiopulmonary resuscitation Cardiogenic shock chronic warfarin anticoagulation LVEF less than 20% other medical illness participation in another investigational drug or device study that has not reached its primary endpoint Left main coronary artery disease with 50% stenosis Ostial target lesion Failure to visualize vessel anatomy distal to the culprit lesion Moderate to heavily calcified target lesion or vessel excessive tortuosity bifurcation with a side branch more than 2.0 mm in diameter A significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent Diffuse disease distal to target lesion with impaired runoff Any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion PCI of another lesion performed within 6 months before the index procedure Target lesion located in a saphenous vein graft

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGuard<br>MGuard stent will be deployed | Device: MGuard<br>* MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.<br>|
| Active Comparator: BMS or DES<br>A regular bare metal stent or drug-eluting stent will be deployed | Device: Control BMS or DES<br>* Control BMS or DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution |  | 60 to 90 minutes after the last angiogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure. | The incidence of TIMI 3 flow at the end of the procedure. | 60-90 minutes after last angiogram | 
| Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure | Major Adverse Cardiac Events (MACE): defined as cardiac death, reinfarction (Q wave and non-Q wave), or repeat ischemia-driven target lesion revascularization (TLR) by percutaneous or surgical methods at hospital discharge, 30 days, 6 months and 1 year post-procedure. | discharge, 30 days, 6 and 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, myocardial infarction, stent