NCT02792920Unknown不适用
Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
Hyogo Brain and Heart Center2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Target vessel failure (TVF)
研究概览
简要总结
To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES.
Also, OCT sub-analysis will be conducted
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with STEMI who are able to undergo CoCr-EES implantation.
- •Patients with no history of PCI in the target vessel
- •Patients who are 20 or older at the time of informed consent
- •Patients who provided written informed consent by himself/herself
- •Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
- •Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended
- •Patients who meet all the following vascular inclusion criteria i.Patients with target lesion in native coronary artery ii.Patients with visual maximum vessel diameter of the target stent site in target lesion
- •Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel
- •Patients who are able to treat with CoCr-EES the diameter 2.5mm or more and 3.5mm or less and the length of 8mm or more and 28mm or less.
排除标准
- •Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study.
- •Patients presenting with cardiogenic shock
- •Patients for whom 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account)
- •Patients with responsible lesion in left main trunk
- •Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
- •Patients on hemodialysis
- •Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel (This may not apply if safety of ticlopidine is confirmed as an alternative drug.)
- •Patients who are below the age of 20
- •Women who were positive in pregnancy test or wish to become pregnant during study duration
- •Patients who newly developed AMI attributable to the prior stented site
- •Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES
- •Patients diagnosed with hepatic insufficiency
- •Patients with target lesion in saphenous vein graft
- •Patients with active malignant tumor
研究组 & 干预措施
CoCr-EES
Other
干预措施: CoCr-EES (Device)
结局指标
主要结局
Target vessel failure (TVF)
时间窗: 12 months
Target vessel failure (TVF) at 12 months after CoCr-EES implantation. TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) or Target Lesion Revascularization (TLR)
次要结局
- Any TLR(12 months and 36 months)
- Any Target Vessel Revascularization (TVR)(12 months and 36 months)
- MI (QMI and Non-QMI)(12 months)
- Death(12 months and 36 months)
- MACE (Cardiac death, MI and TLR)(12 months and 36 months)
- Definite or Probable stent thrombosis(12 months and 36 months)
研究者
研究点 (2)
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