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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGuard | Experimental | MGuard stent will be deployed |
|
| BMS or DES | Active Comparator | A regular bare metal stent or drug-eluting stent will be deployed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGuard | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Abizaid, MD, PhD | Inst Dante Pazzanese of Cardiology, Brazil | Principal Investigator |
| Dariusz Dudek, MD, PhD | Cardiac Catheterization Laboratories, Krakow, Poland | Principal Investigator |
| Sigmund Silber, MD, PhD | Heart Center at the Isar Academic Teaching Site of the University of Munich | Principal Investigator |
| Gregg Stone, MD | Columbia University Medical Center The Cardiovascular Research Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku | Bialystok | Poland | ||||
| Gilghsin: John Paul II Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25603802 | Derived | Dudek D, Dziewierz A, Brener SJ, Abizaid A, Merkely B, Costa RA, Bar E, Rakowski T, Kornowski R, Dressler O, Abizaid A, Silber S, Stone GW. Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001484. doi: 10.1161/CIRCINTERVENTIONS.114.001484. | |
| 25277335 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Control BMS or DES | Device | Control BMS or DES |
|
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 |
| Krakow |
| Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | Poland |
| Oddział Kardiologii Inwazyjnej | Nowy Targ | Poland |
| Centrum Kardiologii Inwazyjnej GVM Carint | Oświęcim | Poland |
| Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw | Poland |
| Milpark Hospital | Johannesburg | South Africa |
| Derived |
| Dudek D, Brener SJ, Rakowski T, Dziewierz A, Abizaid A, Silber S, Yaacoby E, Dizon JM, Costa RA, Maehara A, Dressler O, Stone GW. Efficacy of an Embolic Protection Stent as a Function of Delay to Reperfusion in ST-Segment Elevation Myocardial Infarction (from the MASTER Trial). Am J Cardiol. 2014 Nov 15;114(10):1485-9. doi: 10.1016/j.amjcard.2014.08.007. Epub 2014 Aug 27. |
| 23103033 | Derived | Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyla R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |