FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure

Conditions
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Coronary Artery Insufficiency

Intervention / Treatment
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* Procedure: Intra coronary measures of pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient sent to coronal angioplasty with putting of an active stent to treat a restenosis Exclusion Criteria: acute myocardial infarction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intra coronary measures of pressure | Procedure: Intra coronary measures of pressure<br>* Intra coronary measures of pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images | The first group of patients will have a coronary procedure with stent and his | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam | 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 | At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered | during the study | 
| Complementary examination | Complementary examination | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deployment stent optimisation, Fractional Flow Reserve, Stent, Restenosis, Coronary