慢性四肢威胁性缺血症患者的血管内石症:对CALCIO的研究协议,这是一个潜在的多中心观察性调查
Raman Uberoi1, Peter Reimer2, Joo-Young Chun3
1Department of Radiology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headington, Oxford, OX3 9DU, UK.
Cardiovascular and interventional radiology
|February 17, 2026
概括
这项CALCIO研究将评估慢性四肢威胁性缺血症 (CLTI) 血管内石 (IVL) 的长期结果. 这项研究旨在改善严重血管化患者的内血管治疗决策.
科学领域:
- 血管外科 血管外科
- 干预心脏病学 干预心脏病学
- 血管内治疗疗法 血管内疗法
背景情况:
- 慢性四肢威胁性缺血症 (CLTI) 中严重的血管化使内血管干预复杂化,增加截肢和死亡风险.
- 血管内透症 (IVL) 在CLTI中显示出重新血管化的前景,但长期有效性数据有限.
研究的目的:
- 评估一大批CLTI患者中IVL的现实,长期结果.
- 评估IVL在改善伤口愈合和预防截肢方面的有效性.
- 提供支持CLTI最佳内血管治疗策略的数据.
主要方法:
- 全球,多中心,前性CALCIO观察研究将跟踪400名成年CLTI患者 (罗斯福类别≥4) 接受IVL治疗.
- 主要结局:12个月后,创伤愈合和免于截肢的综合结果.
- 二次结果包括技术成功,没有截肢的生存率,肢体输液,WIfI得分,通透性,再血管化率,安全性和HRQoL.
主要成果:
- 数据收集正在进行中,招生从2024年7月到2026年7月,后续到2028年7月.
- 结果将主要使用描述性统计数据进行报告.
- 该研究已在临床试验.gov (NCT06149650) 上注册.
结论:
- 预计CALCIO研究将对IVL对CLTI的长期临床疗效产生重大见解.
- 这些发现将有助于临床医生做出明智的决策,就重度化的CLTI患者的内血管治疗做出明智的决定.
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