A Study Comparing the Effects of Coronary Rotational Atherectomy and Intravascular Lithotripsy on Coronary Microcirculation in Patients With Severe Calcified Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
The goal of this observational study is to lean that whether the distinct mechanisms by which intravascular lithotripsy (IVL) and rotational atherectomy (RA) treat severe coronary calcification differentially affect the microcirculation, leading to coronary microvascular dysfunction (CMD).
The main question it aims to answer is: we evaluated the prognostic value of post-percutaneous coronary intervention (PCI) CMD, assessed by the angiography-derived index of microcirculatory resistance (angio-IMR), in patients with severe coronary calcification undergoing RA or IVL.
Participants will answer survey questions about their clinical outcomes for 1 year by telephone
详细描述
This retrospective, multicenter, observational study.The study protocol was approved by the institutional review board at participating centers and was conducted in accordance with the principles of the Declaration of Helsinki. Owing to the retrospective nature of the study, the requirement for written informed consent was waived.Consecutive patients who underwent RA or IVL due to serve calcification during the PCI at the three participating centers between January 1, 2018, and October 31, 2024, were included in this retrospective analysis. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length. Exclusion criteria encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients who underwent RA or IVL due to serve calcification during the PCI. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length-
排除标准
- •encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality
研究组 & 干预措施
Intravascular lithotripsy group
Angio-IMR>=25 OR Angio-IMR<25
Rotational atherectomy
Angio-IMR>=25 OR Angio-IMR <25
结局指标
主要结局
MACE
时间窗: 1 year
composite of cardiac death, myocardial infarction, target vessel revascularization, or readmission for unstable angina
次要结局
- target vessel failure(1 year)
