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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Instituto Dante Pazzanese
São Paulo, Brazil
Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
Catania, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Target Vessel Failure (TVF)
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
Time frame: 12 months
Target lesion failure
Composite of cardiac death, target vessel myocardial infarction, target lesion revascularization 2. Target vessel failure (TVF) Comosite of cardiac death, target vessel myocardial infarction, target lesion revascularization
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Target vessel failure
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
Time frame: 1 month, 6 months, 2 and 3 years
Stent thrombosis
Thrombosis in study stents
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
Composite of any death, any myocardial infarction, any coronary revascularization
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Target lesion revascularization
revascularization of treated lesion
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Bleeding
Access or non access site bleeding
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
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Cardiologico Monzino
Milan, Italy
San Raffaele Hospital
Milan, Italy
PHE University Cardiology clinic
Skopje, North Macedonia
Clinical Center of Serbia
Belgrade, Serbia
Clinical Hospital Center Zemun (CHC Zemun)
Belgrade, Serbia
Clinical center Nis (CCNIs)
Niš, Serbia
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
...and 3 more locations
revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
Time frame: 1 month
In-Stent late loss
angiographic assessment of late loss at 6 months
Time frame: 6-mnths