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经皮冠状动脉介入治疗的下一代导引导管扩展系统

A Next-Generation Guide Extension System for Percutaneous Coronary Intervention.

机构信息

CrossLiner, Inc., Kalamazoo, MI, United States of America.

REV-1 Engineering, Murrieta, CA, United States of America.

出版信息

Cardiovasc Revasc Med. 2021 Nov;32:50-55. doi: 10.1016/j.carrev.2020.12.023. Epub 2020 Dec 28.

Abstract

BACKGROUND

Guide catheter extension is an integral part of percutaneous coronary intervention (PCI). First generation guide catheter extension devices are monorail, blunt ended tubular structures with limitations. The CrossLiner™ is a next generation guide extension "system" intended to allow safe, deep, coronary intubation.

METHODS

The CrossLiner was tested in a head-to-head study with the GuideLiner™ and GuideZilla™ in a porcine coronary model, with stenting. Data were collected from 8 coronary vessels from four animals, to evaluate the ability to deeply intubate the vessel with the guide extension.

RESULTS

The CrossLiner crossed distally and through a distal stented segment in 8/8 vessels, while the first-generation devices were stuck proximal to the stent (n=2/8) or at the stent edge (n=4/8), or passed partially into the deployed stent with difficulty (2/8) vessels (p < 0.0002 for deliverability). The average depth of guide extension delivery/ "intubation" was 12.9±3.6 cm for the CrossLiner and 5.6±1.1 cm for the first-generation guide extension (p < 0.001).

CONCLUSIONS

The CrossLiner is a next generation guide extension system that may offer advantages over first generation devices. Further clinical evaluation will be required to assess the role of this new device in PCI.

摘要

背景

导引导管延长是经皮冠状动脉介入治疗(PCI)的一个组成部分。第一代导引导管延长装置是单轨、钝端管状结构,存在局限性。CrossLiner™是一种下一代导引导管延长“系统”,旨在实现安全、深入的冠状动脉插管。

方法

CrossLiner 在一项与 GuideLiner™和 GuideZilla™的头对头研究中,在猪冠状动脉模型中进行了支架置入试验,收集了来自四个动物的 8 个冠状动脉的数据,以评估导引导管延长的能力。

结果

CrossLiner 在 8/8 个血管中成功穿过远端并通过远端支架段,而第一代装置卡在支架近端(n=2/8)或支架边缘(n=4/8),或难以部分穿过已部署的支架(n=2/8)(可输送性方面 p < 0.0002)。CrossLiner 的导引导管延长/“插管”的平均深度为 12.9±3.6 cm,第一代导引导管延长装置为 5.6±1.1 cm(p < 0.001)。

结论

CrossLiner 是一种下一代导引导管延长系统,可能优于第一代装置。需要进一步的临床评估来评估这种新设备在 PCI 中的作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2447/10705001/0ad161ad3b40/nihms-1657580-f0001.jpg

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