Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

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.

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

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