Coronary Artery Insufficiency
Conditions
Keywords
Deployment stent optimisation, Fractional Flow Reserve, Stent, Restenosis, Coronary
Brief summary
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
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
Interventions
PROCEDUREIntra coronary measures of pressure
Intra coronary measures of pressure
Sponsors
Volcano Corporation
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient sent to coronal angioplasty with putting of an active stent to treat a restenosis
Exclusion criteria
* acute myocardial infarction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images | during de study | The first group of patients will have a coronary procedure with stent and his |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 6 months cardiac events will be registered: patients will undergo a |
| At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered | during the study | At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered |
| Complementary examination | during the study | Complementary examination |
Countries
France
Outcome results
None listed