Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

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