血管内溶液系统的安全性和有效性:一个前性的多中心临床试验 (Vigour研究)
Tao Chen1,2, Jiawei Zhao1,2, Yong He3
1Department of Cardiology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China.
概括
在中国患者中,用国内气球有效治疗血管内石化冠状动脉病变. 这种安全而成功的方法提高了船只的合规性,并促进了支架部署.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 在结石化冠状动脉病变中,最佳的斑块制备对于预防支架失效至关重要.
- 在之前的研究中,对于严重的冠状动脉化而言,静脉内石 (IVL) 已经证明了安全性和有效性.
- 这项研究使用国内生产的气球来评估IVL,用于中国的化冠状动脉病变.
研究的目的:
- 用国内生产的气球评估IVL的安全性和有效性.
- 获得冠状动脉IVL在中国严重冠状动脉化患者的批准.
主要方法:
- 预期的,多中心的,单臂的VIGOUR试验 (NCT05818098).
- 主要终点:程序上的成功. 二级终点:装置成功,血管图成功,30天的MACE和并发症.
- 光学连贯性断层扫描 (OCT) 部分研究用于修饰分析.
主要成果:
- 189名患者中有93.7%的程序成功,超过了目标 (87.0%).
- 设备 (98.9%) 和血管图 (98.4%) 的成功率很高.
- 低的30天MACE (5.3%) 和并发症 (0.5%) 率. 在IVL后81.9%的病变中观察到骨折.
结论:
- 使用国内气球的IVL显著提高了血管的遵守性,有助于在化冠状动脉中提供支架.
- 该程序对中国人口来说是有效和安全的.
- 较大的角与OCT上IVL后骨折的可能性增加相关.
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