Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (DeFACTO)
|ClinicalTrials.gov Identifier: NCT01233518|
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: FFR|
|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|
|Primary Completion Date :||November 2011|
|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.
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|