Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •patient sent to coronal angioplasty with putting of an active stent to treat a restenosis
排除标准
- •acute myocardial infarction
研究组 & 干预措施
1
Intra coronary measures of pressure
干预措施: Intra coronary measures of pressure (Procedure)
结局指标
主要结局
The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images
时间窗: during de study
The first group of patients will have a coronary procedure with stent and his
次要结局
- At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam(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(during the study)