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

This study has been completed.
Sponsor:
Collaborators:
Harvard Clinical Research Institute
Los Angeles Biomedical Research Institute
Minneapolis Heart Institute Foundation
Information provided by (Responsible Party):
HeartFlow, Inc.
ClinicalTrials.gov Identifier:
NCT01233518
First received: October 13, 2010
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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 Intervention
Coronary Artery Disease
Device: FFR

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

Further study details as provided by HeartFlow, Inc.:

Primary Outcome Measures:
  • Diagnostic Accuracy of CCTA plus CT-FLOW [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Diagnostic Performance of CCTA plus CT-FLOW at the subject level [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 285
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single arm study
Single arm study
Device: FFR
Fractional flow reserve measured during cardiac catheterization

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233518

Locations
United States, Alabama
Spring Hill Hospital
Mobile, Alabama, United States, 36608
Sponsors and Collaborators
HeartFlow, Inc.
Harvard Clinical Research Institute
Los Angeles Biomedical Research Institute
Minneapolis Heart Institute Foundation
Investigators
Principal Investigator: James K Min, MD, FACC Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: HeartFlow, Inc.
ClinicalTrials.gov Identifier: NCT01233518     History of Changes
Other Study ID Numbers: CP-901-001
Study First Received: October 13, 2010
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by HeartFlow, Inc.:
CCTA Coronary Artery Disease CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014