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

Inclusion Criteria:

• The participant was a man or woman ≥18 years of age.
• The participant had read, signed, and dated an informed consent form (ICF) prior toany study procedures being performed.
• At the time of enrolment, the participant had been scheduled via written documentationto undergo an ICA for the assessment of CAD.
• The participant had undergone a clinically indicated SPECT OR the participant waswilling to undergo SPECT MPI for the purposes of the clinical study.
• The participant was male or was a nonpregnant, nonlactating female who was eithersurgically sterile or was post-menopausal.
• The participant was able and willing to comply with all study procedures as describedin the protocol.

Exclusion Criteria:

• Participants who were pregnant, may possibly be pregnant, or wish (including theirpartners) to became pregnant during the study period, or were lactating.
• Participants who were unable to undergo all of the imaging procedures.
• Participants who had an established diagnosis of CAD as confirmed by any of thefollowing:

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.

• Participants incapable of undergoing either exercise or pharmacological cardiac stresstesting.
• Participants who had a current illness or pathology that, in the opinion of theinvestigator, would pose a significant safety risk for the participant during cardiacstress testing.
• Documented history of heart failure and/or cardiomyopathy and/or prior LV ejectionfraction (LVEF) <50%).
• Participants scheduled for or planning to undergo any cardiac interventionalprocedures between enrolment and ICA.
• Participants undergoing evaluation for heart transplantation or with history of hearttransplantation.
• Participants enrolled in another clinical study within the 30 days prior to beingenrolled in this study or scheduled to participate in another clinical study duringthe 7-day follow-up period of this study.