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

Study Overview
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Brief Summary
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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
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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)

Official Title
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Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study

Conditions
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Acute ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Device: PCI in patients with ST-elevation myocardial infarction
* Device: PCI in patients with ST-elevation myocardial infarction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultimaster, Drug Eluting Stent<br>Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster | Device: PCI in patients with ST-elevation myocardial infarction<br>* Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)<br>* Other names: Primary PCI;|
| Active Comparator: Kaname, Bare metal stent<br>Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname | Device: PCI in patients with ST-elevation myocardial infarction<br>* Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction<br>* Other names: Primary PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) | Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month, 6 months, 12 months, 2 and 3 years | 
| Target vessel failure | Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization | 1 month, 6 months, 2 and 3 years | 
| Stent thrombosis | Thrombosis in study stents | 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 | 1 month, 6 months, 12 months, 2 and 3 years | 
| Target lesion revascularization | revascularization of treated lesion | 1 month, 6 months, 12 months, 2 and 3 years | 
| Bleeding | Access or non access site bleeding | 1 month, 6 months, 12 months, 2 and 3 years | 
| Safety - revascularization, stroke, definite stent thrombosis or major bleeding | revascularization, stroke, definite stent thrombosis or major bleeding at 1 month | 1 month | 
| In-Stent late loss | angiographic assessment of late loss at 6 months | 6-mnths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, PCI, STEMI, Interventional Cardiology