Coronary Artery DiseaseNCT01559493
Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)
An observational study of Coronary Artery Disease and Plaque, Atherosclerotic, run by NHS National Waiting Times Centre Board at 5 sites in 5 countries.
Trial summary
Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI). To investigate the influence of hyperemia on iFR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Plaque, Atherosclerotic
- How many people
- 200 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jan 2012to Feb 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The aim of the present study is to strengthen the results of retrospective comparisons of iFR with FFR by conducting a prospective study in 200 consecutive, unselected patients from 5 different centers.
Who may be able to join
- all consecutive patients undergoing FFR assessment for standard clinical indications.
Who cannot join
- prior CABG
- extremely tortuous, calcified lesions
- coronary artery occlusion
- acute MI within 5 days
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice
Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
- To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).
- To investigate the influence of hyperemia on iFR.
- To test reproducibility of iFR and FFR.
- Conditions
- Coronary Artery Disease, Plaque, Atherosclerotic
- Keywords
- atherosclerotic lesion assessment
- Medical subject headings
- Coronary Artery Disease, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FFR; iFR | Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past
Measured: 30 days
Secondary outcomes (2)
iFR at rest vs iFr during hyperemia
iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia.
Measured: 30 days
Repeatability of iFr and FFR
To test repeatability of iFR and FFR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital, Catharina Ziekenhuis Eindhoven, Onze Lieve Vrouw Hospital, Stockholm South General Hospital, Brno University Hospital, Stanford University
- Responsible party
- Principal investigator, Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board
- Investigators
- Prof Keith G. Oldroyd, Principal investigator, Golden Jubilee National HospitalProf Colin Berry, MD, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559493
- Sponsor's protocol ID
- Version F 2nd Jan 2012
- Status last verified
- Mar 2012
- First submitted
- 14 Feb 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.
PubMed 23395076
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice
- ClinicalTrials.gov ID
- NCT01559493
- Acronym / sponsor ID
- Version F 2nd Jan 2012
- Conditions
- Coronary Artery Disease, Plaque, Atherosclerotic
- Keywords
- atherosclerotic lesion assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital, Catharina Ziekenhuis Eindhoven, Onze Lieve Vrouw Hospital, Stockholm South General Hospital, Brno University Hospital, Stanford University
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Mar 2012 (estimated)
- 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.
Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
- To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).
- To investigate the influence of hyperemia on iFR.
- To test reproducibility of iFR and FFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFR; iFR | – | –Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The aim of the present study is to strengthen the results of retrospective comparisons of iFR with FFR by conducting a prospective study in 200 consecutive, unselected patients from 5 different centers.
Key inclusion criteria (1 listed)
- all consecutive patients undergoing FFR assessment for standard clinical indications.
Key exclusion criteria (4 listed)
- prior CABG
- extremely tortuous, calcified lesions
- coronary artery occlusion
- acute MI within 5 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
Time frame: 30 days
In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past
2 secondary outcomes
iFR at rest vs iFr during hyperemia
Time frame: 30 days
Repeatability of iFr and FFR
Time frame: 30 days
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 21 Mar 2012.
- Derived from this study: PubMed 23395076Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.
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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.
Prof Keith G. Oldroyd principal investigator
Golden Jubilee National Hospital
Prof Colin Berry, MD principal investigator
Golden Jubilee National Hospital
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Plaque, Atherosclerotic, run by NHS National Waiting Times Centre Board at 5 sites in 5 countries.
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 1 inclusion and 4 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 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Czechia, Netherlands, Sweden. 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?
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01559493, which also lists 1 linked publication.
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 21 Mar 2012.