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| Name | Class |
|---|---|
| Acist Medical Systems | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
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The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability.
Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.
The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional flow reserve measure | Device | Comparison of different devices measuring fractional flow reserve |
| Measure | Description | Time Frame |
|---|---|---|
| Simultaneous FFR measure SJM and ACIST | Correlation between simultaneous measures with St Jude medical FFR device and ACIST device | Immediately |
| Simultaneous FFR measure Boston Scientific and ACIST | Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device | Immediately |
| Simultaneous FFR measure Boston Scientific and SJM | Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device | Immediately |
| Measure | Description | Time Frame |
|---|---|---|
| FFR SJM or Boston alone versus simultaneous with ACIST | Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST | Immediately |
| Clinical concordance |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAEN University Hospital | Caen | France |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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Concordance between FFR values >0.80 or <=0.80
| Immediately |
| Drift of the signal | variation between the initial measure in the aorta (equalization) and final measure | immediately |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |