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

HeartFlow

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: FFR

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01233518

CP-901-001

Details and patient eligibility

About

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.

Full 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

Enrollment

285 patients

Sex

All

Ages

18+ years old

Volunteers

No 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