An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

Inclusion Criteria:

- The subject is a man or woman ≥18 years of age.

- The subject has read, signed, and dated an informed consent form (ICF) prior to any
study procedures being performed.

- At the time of enrolment, the subject has been scheduled via written documentation to
undergo an ICA for the assessment of CAD.

- The subject has undergone a clinically indicated SPECT OR the patient is willing to
undergo SPECT MPI for the purposes of the clinical study.

- The subject is male or is a nonpregnant, nonlactating female who is either surgically
sterile or is post-menopausal.

- The subject is able and willing to comply with all study procedures as described in
the protocol.

Exclusion Criteria:

- Patients who are pregnant, may possibly be pregnant, or wish (including their
partners) to become pregnant during the study period, or are lactating.

- Patients who are unable to undergo all of the imaging procedures.

- Patients who have an established diagnosis of CAD as confirmed by any of the
following:

1. Previous myocardial infarction (MI);

2. Previous cardiac catheter angiography showing ≥50% stenosis;

3. Previous coronary revascularisation, such as percutaneous coronary intervention
(PCI), thrombolysis or coronary artery bypass graft (CABG) placement.

- Patients incapable of undergoing either exercise or pharmacological cardiac stress
testing.

- Patients who have a current illness or pathology that, in the opinion of the
investigator, would pose a significant safety risk for the patient during cardiac
stress testing.

- Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection
fraction (LVEF) <50%).

- Patients scheduled for or planning to undergo any cardiac interventional procedures
between enrolment and ICA.

- Patients undergoing evaluation for heart transplantation or with history of heart
transplantation.

- Patients enrolled in another clinical study within the 30 days prior to being enrolled
in this study or scheduled to participate in another clinical study during the 7-day
follow-up period of this study.