Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study

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)

Inclusion Criteria:

• Age equal or more than 18 years
• Chest pain > 20 minutes
• Primary PCI <24h from symptoms onset
• ST-segment elevation of > 1 mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of > 1 mm in > 2 contiguous anterior leads
• Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.5-4.0 mm in diameter that can be covered with one or multiple stents
• Signed informed consent

Exclusion Criteria:

• Female of childbearing potential (age < 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
• Known intolerance to aspirin, clopidogrel, heparin, bivalirudin, cobalt, chromium, nickel, sirolimus or contrast material
• Currently participating in another trial before reaching primary endpoint
• Mechanical complication of acute myocardial infarction (e.g. cardiogenic shock…)
• Acute myocardial infarction secondary to stent thrombosis
• Previously stented infarction related artery (IRA)
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
• Patients with non-cardiac comorbid conditions with life expectancy< 1 year or that may result in protocol non-compliance
• History of bleeding diathesis or known coagulopathy
• Use of oral anticoagulants