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首次在人身上:一种新的355nm激光斑块切除系统用于外周动脉疾病

Hui Wang¹, Lianrui Guo¹, Yiqun Zhang²

¹Xuan Wu Hospital of the Capital Medical University, Beijing, China.

Lasers in medical science

|May 21, 2025

概括

355nm激光斑块清除系统在治疗外围动脉疾病 (PAD) 方面显示出有前途的安全性和可行性. 这项首次在人体上进行的研究显示了良好的通透率和没有重大不良事件,支持其潜在的临床用途.

科学领域:

心血管医学心血管医学
医疗器械医疗器械
干预心脏病学干预心脏病学

背景情况:

周围动脉疾病 (PAD) 显著影响患者的流动性和生活质量.
目前对PAD的治疗有局限性,需要新的治疗方法.
临床前研究表明,355nm固态激光系统与308nm激光相比,提供了更高的性能.

研究的目的:

评估CLA-355nm激光斑块切除系统在患有PAD的人群中的临床安全性和可行性.
评估355nm激光系统在减少动脉狭窄的有效性.

主要方法:

进行了一项前性的,非随机的,首次在人体上的试验.
九名患有PAD的患者使用355nm激光斑块除去系统与药物涂层气球相结合进行了治疗.
主要终点是6个月的初级通透性;次要终点包括再血管化,截肢和死亡. 通过面向设备和主要心血管不良事件来评估安全性.

主要成果:

激光切除术显著减少了直径狭窄 (DS) 从88.09%降至47.94%,在随后的药物涂层气球血管造形术后进一步降至26.07%.
术后的安全性很好,没有观察到设备导向的临床事件.
六个月后,90%的患者保持了初级通透性,100%没有临床驱动的目标病变再血管化,没有重大心血管不良事件,截肢或其他并发症.

结论:

CLA-355nm激光斑块切除装置代表了PAD的一种新的治疗选择.
这项初步的人类研究表明,在PAD患者中进行斑块切除的安全性和可行性很好.
需要进一步的研究来证实这些初步发现在更大的患者队列中.

关键词:

动脉样硬化是一种动脉样硬化.这就是CLA-3555.激光激光器激光器激光器周围动脉疾病周围动脉疾病

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