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临床试验/NCT07699965
NCT07699965进行中(未招募)不适用

A Study Comparing the Effects of Coronary Rotational Atherectomy and Intravascular Lithotripsy on Coronary Microcirculation in Patients With Severe Calcified Lesions

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 590 人开始时间: 2018年1月1日最近更新:
适应症

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

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)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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