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

Terumo

Status

Completed

Conditions

Acute ST Segment Elevation Myocardial Infarction

Treatments

Device: PCI in patients with ST-elevation myocardial infarction

Study type

Interventional

Funder types

Industry

Identifiers

NCT02828683

T120E4

Details and patient eligibility

About

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.

Full description

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)

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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