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Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (DeFACTO)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01233518
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : August 19, 2015
Sponsor:
Collaborators:
Baim Institute for Clinical Research
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Minneapolis Heart Institute Foundation
Information provided by (Responsible Party):
HeartFlow, Inc.

Tracking Information
First Submitted Date  ICMJE October 13, 2010
First Posted Date  ICMJE November 3, 2010
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Official Title  ICMJE Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Brief Summary This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
Detailed Description 285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: FFR
Fractional flow reserve measured during cardiac catheterization
Study Arms  ICMJE Active Comparator: Single arm study
Patients will receive cCTA, ICA, FFR, and cFFR per protocol.
Intervention: Device: FFR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2011)
285
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2010)
238
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >18 years
  • Patients providing written informed consent
  • Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
  • Has undergone >64 multidetector row CCTA within 60 days prior to ICA
  • No cardiac interventional therapy between the CCTA and ICA

Exclusion Criteria:

  • Prior coronary artery bypass graft (CABG) surgery
  • Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
  • Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD
  • Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
  • Recent prior myocardial infarction within 40 days of ICA
  • Known complex congenital heart disease
  • Prior pacemaker or internal defibrillator lead implantation
  • Prosthetic heart valve
  • Significant arrhythmia or tachycardia
  • Impaired chronic renal function (serum creatinine >1.5 mg/dl
  • Patients with known anaphylactic allergy to iodinated contrast
  • Pregnancy or unknown pregnancy status
  • Body mass index >35
  • Patient requires an emergent procedure
  • Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
  • Any active, serious, life-threatening disease with a life expectancy of less than 2 months
  • Inability to comply with study procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01233518
Other Study ID Numbers  ICMJE CP-901-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HeartFlow, Inc.
Study Sponsor  ICMJE HeartFlow, Inc.
Collaborators  ICMJE
  • Baim Institute for Clinical Research
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Minneapolis Heart Institute Foundation
Investigators  ICMJE
Principal Investigator: James K Min, MD, FACC Weill Medical College of Cornell University
PRS Account HeartFlow, Inc.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP