NCT01460966已完成不适用
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)
研究概览
简要总结
Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™) in the aforementioned subgroup of patients at high risk for distal embolism.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed as ACS and meet the following criteria.
- •Patients with acute myocardial infarction or unstable angina within 2 months from onset.
- •Patients who have severe coronary stenosis which require PCI and in whom attenuated plaque ≥ 5mm (longitudinally) by IVUS before PCI is observed prior to balloon dilatation and stent deployment.
排除标准
- •Patients who need balloon expansion (including small diameter balloon) for IVUS catheter crossing.
- •Patients who were resuscitated after dead on arrival
- •Graft lesion or in-stent restenosis lesion
- •Patients on dialysis or renal failure (Cr>1.5mg/dl).
- •Left main trunk lesion
- •Target vessel size is <2.5mm or >5mm
- •Ineligible for PCI
- •Lactating and (possibly) pregnant woman or having possibility of pregnant
- •Patients who are considered ineligible by the attending physician
结局指标
主要结局
Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)
时间窗: a day
次要结局
- Myocardial blush grade(8-12months)
- Incidence of stent thrombosis(8-12months)
- Plaque protrusion by IVUS inside the stent(8-12months)
- Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline(8-12months)
- Rise in CK-MB and troponin I or T the next morning after PCI (Peak of CK too in case of ST-segment elevation myocardial infarction )(a day)
- Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure(10months)
- Corrected TIMI frame count(8-12months)
- TIMI flow grade(8-12months)
- Incidence of any revascularization(8-12months)
研究者
Kiyoshi Hibi
Yokohama City University Medical Center
Yokohama City University Medical Center
研究点 (2)
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