一种新型紫杉醇包被血管成形术导管用于下肢外周动脉疾病的初步研究:一项初步研究。

IF 0.6 Q4 SURGERY
Serpil Şahin, Mehmet Ali Yılmaz
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引用次数: 0

摘要

目的:本研究的目的是报告我们的初步结果和实际经验,关于在不同阶段的下肢外周动脉疾病患者队列中使用新型紫杉醇包被球囊导管。材料和方法:进行了一项前瞻性队列试验研究,研究组共由20例外周动脉疾病患者组成,他们使用BioPath 014或035进行血管内球囊血管成形术,BioPath 014或035是一种新型紫杉醇包被、含有紫胶的球囊导管。11例患者共有13个TASC II-A病变,6例患者共有7个TASC II-B病变,2例患者有TASC II-C病变,2例患者有TASC II-D病变。结果:在13例患者中,一次尝试使用BioPath导管足以治疗总共20个目标病变,而在7例患者中,需要多次尝试使用不同尺寸的BioPath导管。在5例患者中,靶血管的完全或接近完全闭塞最初使用适当大小的慢性全闭塞导管进行治疗。13例(65%)患者在Fontaine分类中至少有一项分类改善,无症状恶化。结论:BioPath紫杉醇包被球囊导管似乎为治疗股腘动脉疾病提供了一种有用的替代装置。这些初步结果需要进一步的研究来证实,以揭示该设备的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A pilot study of a novel paclitaxel-coated angioplasty catheter for lower extremity peripheral artery disease: a pilot study.

Aim: The aim of the study was to report our preliminary results and real-world experiences regarding the use of a novel paclitaxel-coated balloon catheter in a cohort of patients with lower extremity peripheral artery disease at different stages.

Material and methods: A prospective cohort pilot study was conducted and the study group was made up of a total of 20 patients with peripheral artery disease who underwent endovascular balloon angioplasty with BioPath 014 or 035, a novel paclitaxel-coated, shellac containing balloon catheter. Eleven patients had a total of 13 TASC II-A lesions, 6 patients had a total of 7 TASC II-B lesions, 2 patients had TASC II-C lesions, 2 patients had TASC II-D lesions.

Results: In 13 patients, a single attempt with a BioPath catheter was adequate to treat a total of 20 target lesions, whereas in 7 patients more than one attempt with a different sized BioPath catheter was necessary. In 5 patients, total or near-total occlusion in the target vessel was initially treated with an appropriate sized chronic total occlusion catheter. Thirteen (65%) patients had at least one categorical improvement in Fontaine classification and none had symptomatic worsening.

Conclusions: The BioPath paclitaxel-coated balloon catheter seems to offer a useful alternative to the similar devices for treatment of femoral-popliteal artery disease. These preliminary results warrant confirmation with further research to reveal the safety and efficacy of the device.

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来源期刊
CiteScore
0.90
自引率
14.30%
发文量
44
审稿时长
6-12 weeks
期刊介绍: Polish Journal of Thoracic and Cardiovascular Surgery is a quarterly aimed at cardiologists, cardiosurgeons and thoracic surgeons. Includes the original works (experimental, research and development), illustrative and casuistical works about cardiology and cardiosurgery.
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