Acute ST Segment Elevation Myocardial Infarction Clinical Trial
Official title:
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.
MASTER is prospective, randomized (3:1), single blind, controlled, superiority (efficacy) and
non-inferiority (safety and efficacy), multi center, two-arm trial of TCD-10023 (Ultimaster)
drug eluting stent (test) and Kaname bare metal stent (comparator).
Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 3
years.
500 patients with clinical follow up will be randomized in 3:1 ratio (375 in TCD-10023 arm
and 125 in Kaname arm). Among them, 100 patients will be randomized in the same, 3:1 ratio,
to angiographic follow up at 6 months in preselected hospitals (75 in TCD-10023 and 25 in
Kaname arm)
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