N/A
N=285
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01233518 ↗Enrolled (actual)
285
Serious AEs
0.8%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone — 73; 64 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FFR (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HeartFlow, Inc.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone |
73; 64 | — |
| SECONDARY Diagnostic Performance of CCTA Plus FFRCT at the Subject Level |
90; 54; 67; 84 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01233518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.