Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,400
- 试验地点
- 27
- 主要终点
- The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
研究概览
简要总结
The present study was designed to investigate whether the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary percutaneous coronary intervention (PCI) in acute myocardial infarction improve clinical outcomes.
详细描述
Primary percutaneous coronary intervention (PCI) is the preferred strategy for immediate revascularization in patients with acute ST-elevation myocardial infarction (STEMI). A meta-analysis of trials comparing primary PCI to fibrinolytic therapy showed a mortality benefit to the invasive approach. However, although TIMI III flow is achieved in the culprit epicardial vessel in the majority of patients, lack of tissue-level reperfusion is observed in approximately 30% of patients as manifested by persistence of chest pain and ST-segment elevation. Many strategies have tried to overcome this problem, from mechanical thrombectomy and distal protection devices to myocardial preserving agents. The purpose of present study is to investigate the efficacy of the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary PCI in acute myocardial infarction.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset
- •Patients who are eligible for PCI
排除标准
- •History of bleeding diathesis or coagulopathy
- •Known hypersensitivity or contra-indication to contrast agent
- •Left main disease
- •In-stent restenosis lesion
- •Graft vessels lesion
- •Chronic total occlusion lesion
- •Renal dysfunction, creatinine more than 2.0 mg/dL
- •Contraindication to aspirin, clopidogrel or cilostazol
- •Prior PCI or bypass surgery
- •Old myocardial infarction
结局指标
主要结局
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
时间窗: 12 months after index procedure
次要结局
- Stent thrombosis by Academic Research Consortium definition(1 month until 12 months after index procedure)
- All-cause Death(1 month until 12 months after index procedure)
- Cardiac death(1 month until 12 months after index procedure)
- Myocardial infarction(Q or non-Q)(1 month until 12 months after index procedure)
- Target vessel revascularization (clinically- and ischemia-driven)(1 month until 12 months after index procedure)
- Target lesion revascularization (clinically- and ischemia-driven)(1 month until 12 months after index procedure)
- Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade(Day 0 (during PCI procedure))
- Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades(Day 0 (during PCI procedure))
- Left ventricular wall motion improvement(12 months)
- ST segment resolution on ECG after procedure(0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure)
研究者
Seung-Jea Tahk
Dr.
Ajou University School of Medicine