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Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses (DFRiFR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019535
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: physiological assessment with Volcano Verrata pressure wire (iFR)

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 Preliminary unpublished data analyzing physiologic data in benchtop modeling from the VERIFY and CONTRAST studies suggest a very high correlation between iFR and diastolic Pd/Pa.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.

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Study Type : Observational
Estimated Enrollment : 106 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup


Intervention Details:
  • 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 iFR
    Other Name: physiological assessment with Boston Scientific Comet pressure wire (dFR)


Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Marc Sintek, MD 314-454-8475 msintek@wustl.edu
Contact: Kim Striler, RN, MSN 314-747-4452 kstriler@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Marc Sintek, MD    314-454-8475    msintek@wustl.edu   
Principal Investigator: Marc Sintek, MD         
Sponsors and Collaborators
Washington University School of Medicine
Boston Scientific Corporation
Investigators
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Principal Investigator: Marc Sintek, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04019535    
Other Study ID Numbers: 201810120
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Physiologic assessment
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Stenosis
Hyperemia
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases