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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
433
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.
Control BMS or DES
Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku
Bialystok, Poland
Gilghsin: John Paul II Hospital
Krakow, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Oddział Kardiologii Inwazyjnej
Nowy Targ, Poland
The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution
Time frame: 60 to 90 minutes after the last angiogram
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.
Time frame: 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.
Time frame: discharge, 30 days, 6 and 12 months post-procedure
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Centrum Kardiologii Inwazyjnej GVM Carint
Oświęcim, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Poland
Milpark Hospital
Johannesburg, South Africa