Acute ST Segment Elevation Myocardial Infarction
Conditions
Keywords
DES, PCI, STEMI, Interventional Cardiology
Brief summary
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.
Detailed 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)
Interventions
DEVICEPCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Sponsors
Terumo Europe N.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 12 months | Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-Stent late loss | 6-mnths | angiographic assessment of late loss at 6 months |
| Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization | 1 month, 6 months, 12 months, 2 and 3 years | Composite of any death, any myocardial infarction, any coronary revascularization |
| Target lesion revascularization | 1 month, 6 months, 12 months, 2 and 3 years | revascularization of treated lesion |
| Safety - revascularization, stroke, definite stent thrombosis or major bleeding | 1 month | revascularization, stroke, definite stent thrombosis or major bleeding at 1 month |
| Target lesion failure | 1 month, 6 months, 12 months, 2 and 3 years | 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 |
| Target vessel failure | 1 month, 6 months, 2 and 3 years | Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization |
| Stent thrombosis | 1 month, 6 months, 12 months, 2 and 3 years | Thrombosis in study stents |
| Bleeding | 1 month, 6 months, 12 months, 2 and 3 years | Access or non access site bleeding |
Countries
Brazil, Italy, North Macedonia, Serbia, Spain
Outcome results
None listed