FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure
Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.
Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.
研究概览
详细说明
It is a randomized study, intending to treat, comparing the optimisation of the opening out of a stent into a coronar artery either guided with angiographic images only or with the assistance of pressure measurements plus angiographic control.
Several French centers participate to demonstrate superiority of one strategy. The criterion of principal judgement is the whole of cardiac events, criterion made up with the cardiac death, myocardial infarction, revascularisation by coronary bridging and/or angioplasty and positivity of the effort test.
Secondary criterions are :
- comparing cost to efficacy of the two strategies
- evaluating the angiographic restenosis into an under group of 200 patients (100 patients into each group)
- determining the optimal threshold of measurement of intra coronary pressure in a multicentric population
- comparing the ability of the different stents used to optimised the intra coronary pressure measurements
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Paris、法国、75015
- European Georges Pompidou's Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patient sent to coronal angioplasty with putting of an active stent to treat a restenosis
Exclusion Criteria:
- acute myocardial infarction
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Intra coronary measures of pressure
|
Intra coronary measures of pressure
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images
大体时间：during de study
|
The first group of patients will have a coronary procedure with stent and his
|
during de study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam
大体时间：during the study
|
At 6 months cardiac events will be registered: patients will undergo a
|
during the study
|
|
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
大体时间：during the study
|
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
|
during the study
|
|
Complementary examination
大体时间：during the study
|
Complementary examination
|
during the study
|
合作者和调查者
调查人员
- 首席研究员：Antoine LAFONT, Pr,MD,PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- P001003
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