Coronary Artery DiseaseFFR-DSNCT03052803
Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries
An observational study of Coronary Artery Disease and Coronary Stenosis, run by University Hospital, Caen at 1 site in France.
Trial summary
The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
- What is being tested?
- Fractional flow reserve measure
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
Read the detailed description
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.
- Being tested
- Fractional flow reserve measure
- Keywords
- coronary stenosis, fractional flow reserve
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserve measureDevice
Comparison of different devices measuring fractional flow reserve
What is being measured
The primary outcome is the main question the study is designed to answer.
Simultaneous FFR measure SJM and ACIST
Correlation between simultaneous measures with St Jude medical FFR device and ACIST device
Measured: Immediately
Simultaneous FFR measure Boston Scientific and ACIST
Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device
Measured: Immediately
Simultaneous FFR measure Boston Scientific and SJM
Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device
Measured: Immediately
Secondary outcomes (3)
FFR SJM or Boston alone versus simultaneous with ACIST
Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST
Measured: Immediately
Clinical concordance
Concordance between FFR values >0.80 or <=0.80
Measured: Immediately
Drift of the signal
variation between the initial measure in the aorta (equalization) and final measure
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Feb 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Acist Medical Systems, Abbott Medical Devices, Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052803
- Sponsor's protocol ID
- 16-145
- Acronym
- FFR-DS
- Status last verified
- Dec 2017
- First submitted
- 10 Feb 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
- ClinicalTrials.gov ID
- NCT03052803
- Acronym / sponsor ID
- FFR-DS / 16-145
- Keywords
- coronary stenosis, fractional flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Acist Medical Systems, Abbott Medical Devices, Boston Scientific Corporation
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional flow reserve measureComparison of different devices measuring fractional flow reserve | Device | – |
Primary outcome
Simultaneous FFR measure SJM and ACIST
Time frame: Immediately
Correlation between simultaneous measures with St Jude medical FFR device and ACIST device
Simultaneous FFR measure Boston Scientific and ACIST
Time frame: Immediately
Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device
Simultaneous FFR measure Boston Scientific and SJM
Time frame: Immediately
Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device
3 secondary outcomes
FFR SJM or Boston alone versus simultaneous with ACIST
Time frame: Immediately
Clinical concordance
Time frame: Immediately
Drift of the signal
Time frame: immediately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simultaneous FFR measure SJM and ACIST (time frame: Immediately). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.