Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (DeFACTO)
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|ClinicalTrials.gov Identifier: NCT01233518|
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: FFR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||285 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Active Comparator: Single arm study
Patients will receive cCTA, ICA, FFR, and cFFR per protocol.
Fractional flow reserve measured during cardiac catheterization
- Diagnostic Accuracy of CCTA plus CT-FLOW [ Time Frame: 1 day ]Diagnostic accuracy of CCTA plus CT-FLOW to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject level using binary outcomes when compared to FFR as the reference standard.
- Diagnostic Performance of CCTA plus CT-FLOW at the subject level [ Time Frame: 1 day ]Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard.
- Diagnostic Performance CCTA plus CT-FLOW at the vessel level [ Time Frame: 1 day ]Diagnostic performance (accuracy, sensitivity, specificity, PPV and NPV) of CCTA plus CT-FLOW for the presence or absence of HD-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
- FFR Numerical Correlation [ Time Frame: 1 day ]Per-vessel correlation of the CT-FLOW numerical value alone with the FFR numerical value measured during cardiac catheterization.
- Predicted Post-PCI FFR Measurement [ Time Frame: 1 day ]Diagnostic accuracy of predicted post-percutaneous intervention (PCI) CT-FLOW alone to determine success or failure** of PCI using binary outcomes when compared to post-PCI FFR at the subject and vessel level using PCI as the reference standard. **PCI success will be defined as post-PCI FFR>0.80, while PCI failure will be defined as post-PCI FFR≤0.80 during adenosine-mediated hyperemia.
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): NCT01233518
|United States, Alabama|
|Spring Hill Hospital|
|Mobile, Alabama, United States, 36608|
|Principal Investigator:||James K Min, MD, FACC||Weill Medical College of Cornell University|