Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries
NCT ID: NCT03052803
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2017-02-01
2017-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Fractional flow reserve measure
Comparison of different devices measuring fractional flow reserve
Eligibility Criteria
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Inclusion Criteria
* Coronary stenosis needing FFR evaluation according to recommendations
* More than 18 years old
* Clinically stable
* De novo coronary stenosis
* Affiliated to social security
* Informed consent signed
Exclusion Criteria
* Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker)
* History of coronary artery bypass
* intra-stent restenosis
* Patient not capable of understanding the study
* Informed consent not signed
18 Years
ALL
No
Sponsors
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Acist Medical Systems
INDUSTRY
Abbott Medical Devices
INDUSTRY
Boston Scientific Corporation
INDUSTRY
University Hospital, Caen
OTHER
Responsible Party
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Locations
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CAEN University Hospital
Caen, , France
Countries
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Other Identifiers
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16-145
Identifier Type: -
Identifier Source: org_study_id
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