Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study -
Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study -
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DOI：
10.1253/circj.cj-20-1174
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发表时间：
2021-06-01
影响因子：
3.3
通讯作者：
Shibata, Yoshisato
中科院分区：
文献类型：
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作者：
Saito, Shigeru;Yamazaki, Seiji;Shibata, Yoshisato
背景：血管内碎石术(IVL)提供声波压力波，以修改钙离子，增强血管顺应性，并优化支架部署。这项研究的目的是在日本人群中评估IVL治疗涉及严重钙化冠状动脉的新生狭窄的安全性和有效性。方法和结果：Disrupt CAD IV(NCT04151628)是一项为日本监管机构批准的冠状动脉IVL(SWM-1234)而设计的前瞻性多中心研究。主要的安全终点是在30天内不发生重大不良心脏事件(MACE)。主要的疗效终点是手术成功(残余狭窄
Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance and optimize stent deployment. The objective of this study was to assess the safety and effectiveness of IVL treatment of de novo stenoses involving severely calcified coronary vessels in a Japanese population.Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, multicenter study designed for Japanese regulatory approval of coronary IVL (SWM-1234). The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days. The primary effectiveness endpoint was procedural success (residual stenosis