周围动脉化的静脉内溶液:来自RESTORE ATK研究的30天和6个月的结果.
Marianne Brodmann1, Oliver Schlager2, Martin Werner3
1Department of Internal Medicine, Division of Angiology, Medical University of Graz, Graz, Austria.
Journal of vascular and interventional radiology : JVIR
|March 11, 2026
概括
静脉内石流症 (IVL) 在外周动脉疾病患者中有效治疗化膝盖以上病变. 在SEISMIQ IVL系统没有显示任何重大不良事件和持续的临床改善.
科学领域:
- 心血管干预 心血管干预
- 周围动脉疾病的治疗方法
- 医疗器械技术 医疗器械技术
背景情况:
- 化股骨损伤在外周动脉疾病 (PAD) 管理中带来了重大挑战.
- 严重化的传统治疗方法可能是有限的,增加了手术风险.
- 血管内透症 (IVL) 提供了一种新的方法来治疗复杂的化病变.
研究的目的:
- 为了评估SEISMIQ血管内溶液 (IVL) 系统的安全性和有效性.
- 评估IVL在治疗PAD患者膝盖上方化病变 (ATK) 的疗效.
- 为了确定IVL治疗后主要不良事件 (MAE) 和临床结果的发生率.
主要方法:
- 前性,单臂RESTORE ATK研究,涉及95名中度至重度化ATK病变的患者.
- 使用SEISMIQ IVL系统进行治疗,没有附加的药物排泄技术.
- 主要终点: <50%的残余直径狭窄和30天的MAE (死亡,CD-TLR,重大截肢).
主要成果:
- 所有患者在IVL后实现了<50%的残留狭窄,平均残留狭窄率为21.2%.
- 在30天内没有报告重大不良事件 (MAE).
- 6个月后,目标病变的通透率为66.3%,无CD-TLR的自由率为97.9%,并且观察到显著的鲁瑟福分类改进.
结论:
- 在PAD中治疗化ATK病变时,SEISMIQ IVL系统是安全有效的.
- IVL成功地减少了性狭窄症,并发症最小.
- 经过6个月的随访,持续的临床改善得到了证明.
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