Coronary Artery DiseaseDFRiFRNCT04019535
Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses
An observational study of Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- physiological assessment with Volcano Verrata pressure wire (iFR)
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 31 Dec 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
Who may be able to join
- Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
- Age 18-90 year old
- Single worst lesion per patient- Patients may have more than one lesion assessed but only 1 lesion will be evaluated per patient in this study
Who cannot join
- STEMI- Angiographic severity of 40-70% that operator feels needs physiologic assessment in setting of STEMI or 48hours within STEMI
- Atrial fibrillation
- Inability to provide informed consent- No surrogate or healthcare proxy will be allowed to consent for this study
- Severe tortuosity- Vessel tortuosity that the operator feels would be difficult to pass 2 pressure wires down or where pseudo lesions may be formed.
- Saphenous Vein Graft Lesion
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.
Read the detailed description
With the release of DEFINE-FLAIR and iFR SWEDEHEART, coronary physiology and namely iFR, have robust clinical data supporting its routine use in the cardiac catheterization lab. Unfortunately, iFR is a proprietary algorithm owned by Phillips Volcano Corporation (San diego, California, USA) limiting the use of iFR to those centers with Volcano hardware. Whole cardiac cycle Pd/Pa has been another resting measure that has been evaluated and generally performs poorly compared to FFR. Although iFR is measured during the wave free period in diastole, to date there has been no assessment of diastolic Pd/Pa measurements and its potential correlation with the severity of coronary stenoses. Most importantly, evaluating the pressure differential across the entirety of diastole must by definition contain the "iFR value" and therefore should correlate very close with the iFR assessment. Preliminary unpublished data analyzing physiologic data in benchtop modeling from the VERIFY and CONTRAST studies suggest a very high correlation between iFR and diastolic Pd/Pa. This relationship strengthens when measurements are limited to 65% of diastole, hereby named the Diastolic hyperemia-Free Ratio (DFR). These data strongly suggest that DFR could be used as surrogate for iFR when iFR is not available and thus leverage the large clinical outcomes data for iFR in a new measure that is widely available to all standard coronary pressure wires.
Although this preliminary data is strong, none of these measures where made prospectively in actual patients and the iFR was measured off simulated benchtop pressure waveform modeling. This study aims to perform a real-time correlation and agreement between iFR and DFR in patients with moderate coronary stenoses and indications for physiologic assessment.
- Conditions
- Coronary Artery Disease
- Being tested
- physiological assessment with Volcano Verrata pressure wire (iFR)
- Keywords
- Physiologic assessment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiological assessment with Volcano Verrata pressure wire (iFR)Device
Also called physiological assessment with Boston Scientific Comet pressure wire (dFR)
physiological assessment of the coronary lesion will be made with both iFR and dFR. all clinical decisions will be made based on the results of iFR
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of iFR and DFR
. DFR will be correlated, in VIVO, with the gold standard, diastolic coronary blood flow measurement, the instantaneous wave free ratio (iFR). Both DFR and iFR will be correlated simultaneously during the index procedure in patients with moderate coronary stenoses whom hemodynamic assessment was clinically indicated.
Measured: The correlation between values will be the primary endpoint measured and occurs only during the index procedure.
Agreement for treatment with iFR
. how many patients would be treated differently using iFR vs. DFR
Measured: after all subjects are enrolled the RedCap data will be evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start22 Aug 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Washington University School of MedicineThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Marc Sintek, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019535
- Sponsor's protocol ID
- 201810120
- Acronym
- DFRiFR
- Status last verified
- Jan 2025
- First submitted
- 29 Mar 2019
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses
- ClinicalTrials.gov ID
- NCT04019535
- Acronym / sponsor ID
- DFRiFR / 201810120
- Conditions
- Coronary Artery Disease
- Keywords
- Physiologic assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Jul 2019 (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.
A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.
Detailed description
With the release of DEFINE-FLAIR and iFR SWEDEHEART, coronary physiology and namely iFR, have robust clinical data supporting its routine use in the cardiac catheterization lab. Unfortunately, iFR is a proprietary algorithm owned by Phillips Volcano Corporation (San diego, California, USA) limiting the use of iFR to those centers with Volcano hardware. Whole cardiac cycle Pd/Pa has been another resting measure that has been evaluated and generally performs poorly compared to FFR. Although iFR is measured during the wave free period in diastole, to date there has been no assessment of diastolic Pd/Pa measurements and its potential correlation with the severity of coronary stenoses. Most importantly, evaluating the pressure differential across the entirety of diastole must by definition contain the "iFR value" and therefore should correlate very close with the iFR assessment. Preliminary unpublished data analyzing physiologic data in benchtop modeling from the VERIFY and CONTRAST studies suggest a very high correlation between iFR and diastolic Pd/Pa. This relationship strengthens when measurements are limited to 65% of diastole, hereby named the Diastolic hyperemia-Free Ratio (DFR). These data strongly suggest that DFR could be used as surrogate for iFR when iFR is not available and thus leverage the large clinical outcomes data for iFR in a new measure that is widely available to all standard coronary pressure wires.
Although this preliminary data is strong, none of these measures where made prospectively in actual patients and the iFR was measured off simulated benchtop pressure waveform modeling. This study aims to perform a real-time correlation and agreement between iFR and DFR in patients with moderate coronary stenoses and indications for physiologic assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
Key inclusion criteria (3 listed)
- Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
- Age 18-90 year old
- Single worst lesion per patient- Patients may have more than one lesion assessed but only 1 lesion will be evaluated per patient in this study
Key exclusion criteria (5 listed)
- STEMI- Angiographic severity of 40-70% that operator feels needs physiologic assessment in setting of STEMI or 48hours within STEMI
- Atrial fibrillation
- Inability to provide informed consent- No surrogate or healthcare proxy will be allowed to consent for this study
- Severe tortuosity- Vessel tortuosity that the operator feels would be difficult to pass 2 pressure wires down or where pseudo lesions may be formed.
- Saphenous Vein Graft Lesion
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 |
|---|---|---|
| physiological assessment with Volcano Verrata pressure wire (iFR)Also: physiological assessment with Boston Scientific Comet pressure wire (dFR)physiological assessment of the coronary lesion will be made with both iFR and dFR. all clinical decisions will be made based on the results of iFR | Device | – |
Primary outcome
Correlation of iFR and DFR
Time frame: The correlation between values will be the primary endpoint measured and occurs only during the index procedure.
. DFR will be correlated, in VIVO, with the gold standard, diastolic coronary blood flow measurement, the instantaneous wave free ratio (iFR). Both DFR and iFR will be correlated simultaneously during the index procedure in patients with moderate coronary stenoses whom hemodynamic assessment was clinically indicated.
Agreement for treatment with iFR
Time frame: after all subjects are enrolled the RedCap data will be evaluated
. how many patients would be treated differently using iFR vs. DFR
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 13 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Marc Sintek, MD principal investigator
Washington University School of Medicine
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, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 5 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 13 Jan 2025. 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 United States. 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?
Correlation of iFR and DFR (time frame: The correlation between values will be the primary endpoint measured and occurs only during the index procedure.). The study lists 2 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 13 Jan 2025.