Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ultimaster, Drug Eluting Stent
Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster
干预措施: PCI in patients with ST-elevation myocardial infarction (Device)
Kaname, Bare metal stent
Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
干预措施: PCI in patients with ST-elevation myocardial infarction (Device)
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 12 months
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
次要结局
- Safety - revascularization, stroke, definite stent thrombosis or major bleeding(1 month)
- In-Stent late loss(6-mnths)
- Target vessel failure(1 month, 6 months, 2 and 3 years)
- Stent thrombosis(1 month, 6 months, 12 months, 2 and 3 years)
- Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization(1 month, 6 months, 12 months, 2 and 3 years)
- Target lesion revascularization(1 month, 6 months, 12 months, 2 and 3 years)
- Target lesion failure(1 month, 6 months, 12 months, 2 and 3 years)
- Bleeding(1 month, 6 months, 12 months, 2 and 3 years)