NCT00264030已完成2 期
Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Absolute ST segment resolution.
研究概览
简要总结
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.
详细描述
This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.
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
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
- •Acute myocardial infarction < 12 hours with ST segment elevation > 2 mm in at least 2 contiguous leads;
- •Clinical indication of primary PTCA;
- •De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
- •Target lesion stenosis is > 80% (by visual estimation).
排除标准
- •Patient has unprotected left main coronary disease with > 50% stenosis in case left coronary artery is treated;
- •Patient has an ostial target lesion;
- •Killip class > 3.
结局指标
主要结局
Absolute ST segment resolution.
时间窗: post-PTCA
次要结局
- ST segment resolution (> 50% decrease).(pre- and post-PTCA)
- TIMI Frame Count(post PTCA)
- Composite endpoint of slow flow, no reflow or distal embolization.(at anytime)
- Regional wall motion index by echocardiography.(discharge and 6 month follow-up)
- Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.(post-procedure)
- Cardiac function assessed by echocardiography.(before discharge and at 6 month follow-up)
研究者
研究点 (2)
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