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Completed

NCT Number: NCT01233518

Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spring Hill Hospital

Mobile, Alabama, 36608, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FFR

Device

Fractional flow reserve measured during cardiac catheterization

Primary outcomes

  1. Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone

    Time frame: 1 day

    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 outcomes

  1. Diagnostic Performance of CCTA Plus FFRCT 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.

Sponsors and collaborators

Lead sponsor

HeartFlow, Inc.

Industry

Collaborators

  • Baim Institute for Clinical Research
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Minneapolis Heart Institute Foundation

Registry information

Acronym: DeFACTO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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