Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries
FFR-DS
1 other identifier
observational
30
1 country
1
Brief Summary
The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 25, 2018
December 1, 2017
10 months
February 10, 2017
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
FFR SJM or Boston alone versus simultaneous with ACIST
Immediately
Clinical concordance
Immediately
Drift of the signal
immediately
Interventions
Comparison of different devices measuring fractional flow reserve
Eligibility Criteria
Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation
You may qualify if:
- Patients hospitalized at Caen University Hospital for coronary angiography
- 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
You may not qualify if:
- Unstable patients defined by acute coronary syndrome \< 7 days
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- Acist Medical Systemscollaborator
- Abbott Medical Devicescollaborator
- Boston Scientific Corporationcollaborator
Study Sites (1)
CAEN University Hospital
Caen, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 14, 2017
Study Start
February 1, 2017
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 25, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share