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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FFR
Sponsored by
HeartFlow, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CCTA Coronary Artery Disease CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spring Hill Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm study

Arm Description

Patients will receive cCTA, ICA, FFR, and cFFR per protocol.

Outcomes

Primary Outcome Measures

Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) 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 invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values >0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and <50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.

Secondary Outcome Measures

Diagnostic Performance of CCTA Plus FFRCT at the Subject Level
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.

Full Information

First Posted
October 13, 2010
Last Updated
January 20, 2021
Sponsor
HeartFlow, Inc.
Collaborators
Baim Institute for Clinical Research, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Minneapolis Heart Institute Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01233518
Brief Title
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Acronym
DeFACTO
Official Title
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeartFlow, Inc.
Collaborators
Baim Institute for Clinical Research, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Minneapolis Heart Institute Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CCTA Coronary Artery Disease CAD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Other
Arm Description
Patients will receive cCTA, ICA, FFR, and cFFR per protocol.
Intervention Type
Device
Intervention Name(s)
FFR
Intervention Description
Fractional flow reserve measured during cardiac catheterization
Primary Outcome Measure Information:
Title
Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
Description
Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) 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 invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values >0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and <50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Diagnostic Performance of CCTA Plus FFRCT at the Subject Level
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Min, MD, FACC
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spring Hill Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21930103
Citation
Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GB, Mauri L, Schwartz RS, Shaw LJ. Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study. J Cardiovasc Comput Tomogr. 2011 Sep-Oct;5(5):301-9. doi: 10.1016/j.jcct.2011.08.003. Epub 2011 Aug 7.
Results Reference
background
PubMed Identifier
22922562
Citation
Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
Results Reference
result
PubMed Identifier
25592691
Citation
Park HB, Heo R, O Hartaigh B, Cho I, Gransar H, Nakazato R, Leipsic J, Mancini GBJ, Koo BK, Otake H, Budoff MJ, Berman DS, Erglis A, Chang HJ, Min JK. Atherosclerotic plaque characteristics by CT angiography identify coronary lesions that cause ischemia: a direct comparison to fractional flow reserve. JACC Cardiovasc Imaging. 2015 Jan;8(1):1-10. doi: 10.1016/j.jcmg.2014.11.002.
Results Reference
derived

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Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

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