A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,504
- 试验地点
- 11
- 主要终点
- Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year.
研究概览
简要总结
This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.
Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.
详细描述
Primary PCI, with or without stenting, has been shown to result in superior long-term outcome when compared to thrombolytic therapy in patients with acute myocardial infarction (MI).
Recently, several studies showed that both sirolimus- and paclitaxel-eluting stents are more effective in reducing restenosis and the frequency of repeat interventions than bare metal stents, which rapidly resulted in an unrestricted use of drug-eluting stents, also in patients with ST segment elevation MI (STEMI). , , , Shortly after the introduction of the sirolimus-eluting stent in April 2002 the first studies appeared, hypothesizing that the therapeutic range of sirolimus-eluting stents could be extended to patients presenting with MI. When compared to bare metal stents, sirolimus-eluting stents were associated with less restenosis and target vessel revascularization (TVR) up until one year of follow-up. , At present, it is unclear whether this also holds for paclitaxel-eluting stents.4,
Everolimus is a sirolimus analogue, an effective anti-proliferative agent that inhibits growth factor-stimulated cell proliferation by causing cell cycle arrest in the late G1 stage in the cell cycle.
The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.
This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following criteria
- •Patients presenting with a ST-elevation myocardial infarction <12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation
- •Cardiogenic shock.
- •Rescue PCI after failed thrombolysis.
- •PCI indicated early (<24h) after effective thrombolysis following current ESC guidelines.
- •Patients presenting late ("latecomers") with ST-elevation myocardial infarction (>12h-48h) after the onset of symptoms.
- •Written informed consent.
- •The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.
- •Angiographic:
- •Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.
排除标准
- •Age < 18 years.
- •Pregnancy or breastfeeding.
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.
- •Patients with absolute indication of being chronic treated with acenocoumarol
- •Myocardial infarction due to a previously implanted stent thrombosis
- •Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).
研究组 & 干预措施
Everolimus Arm
Everolimus Eluting Coronary Stent System
干预措施: Everolimus Eluting Coronary Stent System (Drug)
non drug eluting stent Arm
cobalt chromium balloon expandable stent
干预措施: cobalt chromium balloon expandable stent ( non drug eluting stent Arm) (Device)
结局指标
主要结局
Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year.
时间窗: 1 year
次要结局
- All cause and cardiac mortality(at 1 year and yearly up to 5 years)
- Recurrent myocardial infarction(at 1 year and yearly up to 5 years)
- Target lesion revascularization(at 1 year and yearly up to 5 years)
- Stent thrombosis(at 1 year and yearly up to 5 years)
- Clinical procedure success(procedure moment)
- Target vessel revascularization(at 1 year and yearly up to 5 years)
- Clinical device success(Procedure moment)
- Major and minor bleeding(at 1 year and yearly up to 5 years)
研究者
Dr. Sabate
Doctor
Hospital Clinic of Barcelona