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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
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.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: FFR Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single arm study
Patients will receive cCTA, ICA, FFR, and cFFR per protocol.
Device: FFR
Fractional flow reserve measured during cardiac catheterization




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01233518


Locations
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United States, Alabama
Spring Hill Hospital
Mobile, Alabama, United States, 36608
Sponsors and Collaborators
HeartFlow, Inc.
Baim Institute for Clinical Research
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Minneapolis Heart Institute Foundation
Investigators
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Principal Investigator: James K Min, MD, FACC Weill Medical College of Cornell University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HeartFlow, Inc.
ClinicalTrials.gov Identifier: NCT01233518    
Other Study ID Numbers: CP-901-001
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by HeartFlow, Inc.:
CCTA Coronary Artery Disease CAD
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases