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

Launched by TERUMO EUROPE N.V. · Jul 11, 2016

Keywords

ClinConnect Summary

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 hospital...

Gender

ALL

Eligibility criteria

• 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

Trial Officials