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| Name | Class |
|---|---|
| Volcano Corporation | INDUSTRY |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intra coronary measures of pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra coronary measures of pressure | Procedure | Intra coronary measures of pressure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine LAFONT, Pr,MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Georges Pompidou's Hospital | Paris | 75015 | France |
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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 |