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首页> 外文期刊>Journal of cardiovascular medicine >ClearWayRX system to reduce intracoronary thrombus in patients with acute coronary syndromes according to optical coherence tomography after abciximab intracoronary local infusion trial (COCTAIL): study rationale and design.
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ClearWayRX system to reduce intracoronary thrombus in patients with acute coronary syndromes according to optical coherence tomography after abciximab intracoronary local infusion trial (COCTAIL): study rationale and design.

机译：根据abciximab冠状动脉局部输注试验（COCTAIL）后的光学相干断层扫描技术，ClearWayRX系统可减少急性冠状动脉综合征患者的冠状动脉内血栓：研究原理和设计。

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BACKGROUND AND OBJECTIVE: Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACS) improves clinical outcomes through salvage of myocardial tissue. Although use of intracoronary glycoprotein IIb/IIIa inhibition with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain. The purpose of this trial is to evaluate the efficacy and safety of an intracoronary bolus of abciximab delivered using the ClearWayRX Therapeutic Perfusion Catheter followed by a dosing regimen of intravenous abciximab infusion after PCI, compared with intracoronary abciximab infusion, via the guiding catheter, followed by a dosing regimen of intravenous abciximab infusion after PCI in patients with ACS. STUDY DESIGN: Patients with ACS (either unstable anginaon-ST-elevation myocardial infarction or ST-elevation myocardial infarction with open infarct-related artery) and visible thrombus referred for PCI will be randomized to receive one of the two treatment regimens: local intracoronary infusion of abciximab through the ClearWayRX System or intracoronary infusion of abciximab via the guiding catheter. Both groups will receive intravenous infusion of abciximab during the 12-h period following the procedure. Optical coherence tomography assessment will be performed prior to abciximab administration and after the intracoronary infusions to document the change in the thrombus score. In addition, postintervention assessments of coronary microcirculatory function will be evaluated by means of the corrected thrombolysis in myocardial infarction frame count flow and the 'myocardial blush grade'. IMPLICATIONS: If local intracoronary infusion of abciximab through the ClearWayRX System significantly reduces thrombus burden, it will lend support to the use of this delivery system as a valuable tool in patients with ACS treated with PCI.
机译：背景与目的：在急性冠脉综合征（ACS）的情况下，经皮冠状动脉介入治疗（PCI）及时再灌注可通过抢救心肌组织改善临床疗效。尽管通过PCI抑制冠状动脉内糖蛋白IIb / IIIa可以提高正常心外膜血流和心肌灌注的速度，但仍存在一些未满足的需求。这项试验的目的是评估使用ClearWayRX治疗性灌注导管先行冠状动脉内abciximab推注，然后在PCI后静脉内注射abciximab的给药方案，与通过引导导管进行冠状动脉内abciximab输注，然后进行引导的疗效和安全性ACS患者PCI后静脉注射abciximab的给药方案。研究设计：ACS（不稳定型心绞痛/非ST段抬高型心肌梗塞或ST段抬高型心肌梗塞伴开放性梗塞相关动脉）和可见血栓行PCI的患者将被随机分配接受以下两种治疗方案之一：局部通过ClearWayRX系统在冠状动脉内注射abciximab或通过引导导管在冠状动脉内注射abciximab。两组均在手术后的12小时内接受abciximab的静脉输液。光学相干断层扫描评估将在给予阿昔单抗之前和冠状动脉内输注之后进行，以记录血栓评分的变化。此外，将通过校正后的心肌梗死框架计数流量和“心肌腮红等级”中的溶栓治疗评估冠状动脉微循环功能的干预后评估。含义：如果通过ClearWayRX系统在冠状动脉内局部注射abciximab，可显着减轻血栓负担，则将支持该输送系统作为PCI治疗ACS患者的重要工具。

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