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临床试验/NCT04281212
NCT04281212已完成不适用

Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

French Cardiology Society1 个研究点 分布在 1 个国家目标入组 1,303 人开始时间: 2020年3月9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
1,303
试验地点
1
主要终点
Success of the angioplasty for management of CTO

研究概览

简要总结

Data from the literature on the management of Chronic Coronary Occlusions (CTO) in France highlight a lack of epidemiological data on these patients at the national level.

For this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in France, to study the prevalence of CTOs in France as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, CTO angioplasties in terms of success rates, complications, medico-economic impact.

详细描述

This exhaustive and descriptive study of CTO patients, performed on a set of approximately 100 interventional cardiology centers in France, will be conducted in two steps:

  • 1st step: This collection will be done over one month, the objective of which will be to photograph the therapeutic choice in the management of CTO (drug, surgical, endovascular approach).
  • 2nd step: a second collection will be carried out over a period of two months, the objective of which will be to evaluate, in patients presenting a CTO with an attempt at angioplasty, the success of the procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient over 18 years old
  • Patient with CTO

排除标准

  • Patient with acute occlusion or subocclusive lesion or CTO of less than 3 months
  • Patient expressing his refusal to participate in the observatory
  • Inclusion Criteria:
  • Patient over 18 years old
  • Patient with CTO who has attempted angioplasty
  • Exclusion Criteria:
  • Patient with acute occlusion or less than 3 months.
  • Patient demonstrating refusal to participate in the observatory

结局指标

主要结局

Success of the angioplasty for management of CTO

时间窗: Through the end of hospitalization, an average of 5 days

Procedural success rate defined by residual stenosis ≤ 30% with a TIMI (Thrombolysis In Myocardial Infarction) 3 flow and no hospital complications at the end of the angioplasty procedure

Choice of treatment in management of patients with CTO

时间窗: Through the end of hospitalization, an average of 5 days

Rate of patients with CTO treated by medical treatment alone and/or by surgery, and/or by angioplasty

次要结局

  • Rate of events occured after procedure of angioplasty during the hospitalization, for patients with CTO(Through the end of hospitalization, an average of 5 days)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (1)

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