Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses (DFRiFR)
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|ClinicalTrials.gov Identifier: NCT04019535|
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : August 31, 2020
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: physiological assessment with Volcano Verrata pressure wire (iFR)|
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 Preliminary unpublished data analyzing physiologic data in benchtop modeling from the VERIFY and CONTRAST studies suggest a very high correlation between iFR and diastolic Pd/Pa.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 Type :||Observational|
|Estimated Enrollment :||106 participants|
|Official Title:||Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses|
|Actual Study Start Date :||August 22, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
- Device: physiological assessment with Volcano Verrata pressure wire (iFR)
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 iFROther Name: physiological assessment with Boston Scientific Comet pressure wire (dFR)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019535
|Contact: Marc Sintek, MDemail@example.com|
|Contact: Kim Striler, RN, MSNfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Marc Sintek, MD 314-454-8475 email@example.com|
|Principal Investigator: Marc Sintek, MD|
|Principal Investigator:||Marc Sintek, MD||Washington University School of Medicine|