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临床试验/NCT06446102
NCT06446102已完成不适用

Bifurcation Coronary Lesion 0-0-1

RCF@ICPS3 个研究点 分布在 2 个国家目标入组 273 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
273
试验地点
3
主要终点
Major Adverse Cardiovascular Events

研究概览

简要总结

Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study.

To retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.

详细描述

The primary objective of the trial is to estimate the frequency of Major Adverse Cardiac Events (MACE), including cardiac death, myocardial infarction within the territory of the treated lesion, and revascularization of the target lesion in a representative population of patients treated by coronary angioplasty of type 0-0-1 bifurcation lesions.

The sample size will be determined by the number of angioplasties of type 0-0-1 bifurcation lesions performed at each center between 2016 and 2022.

Since the trial is observational in nature and there are no previously published studies, the sample size cannot be calculated based on the desired precision of the estimation.

Furthermore, the purpose of the study is also to assess the techniques used to treat this type of coronary bifurcation and to highlight any differences between different centers and with other types of coronary bifurcation lesions described in the literature.

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

  • Male or female aged 18 years and older,
  • Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.

排除标准

  • Opposing the collection and processing of necessary data and refusing additional telephone follow-up

结局指标

主要结局

Major Adverse Cardiovascular Events

时间窗: 3 years

Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.

次要结局

  • Target lesion revascularization(3 years)

研究者

发起方
RCF@ICPS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca SANGUINETI

Principal Investigator

GCS Ramsay Santé pour l'Enseignement et la Recherche

研究点 (3)

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