A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes

Inclusion Criteria:

• • The participant was a man or woman ≥18 years of age
• The participant was undergoing evaluation of known CAD or for suspected CAD withan intermediate to high PTP.
• The participant had read, signed, and dated an informed consent form (ICF) priorto any study procedures being performed, and was willing to allow the studyinvestigator to make the participant's medical records available to GEHealthcare.
• The participant was male or was a nonpregnant, nonlactating female who was eithersurgically sterile (had a documented bilateral tubal ligation and oophorectomyand/or documented hysterectomy [bilateral tubal ligation alone was insufficient])or was post-menopausal (cessation of menses for more than 1 year); enrollment inthe study without a pregnancy test at Screening was allowed for these categoriesof female participants. For women of childbearing potential, the results ofeither a urine or serum human chorionic gonadotropin pregnancy test (with theresult known on the day of each radiopharmaceutical administration) must benegative. These participants must have been practicing appropriate birth controlfrom the time of the screening to 30 days after the second radiopharmaceuticaladministration. Such methods included: hormonal contraception including oralcontraceptives; intrauterine device; intrauterine hormone releasing system;bilateral tubal occlusion; vasectomized partner; sexual abstinence; adequatebarrier method with spermicide (e.g., diaphragm, condom).
• The participant was able and willing to comply with all study procedures asdescribed in the protocol.

Exclusion Criteria:

• • Participants who were pregnant, may possibly be pregnant, or wish (including theirpartners) to become pregnant during the study period, or were lactating
• Participants who were unable to undergo all of the imaging procedures
• Participant with unstable cardiovascular condition, including but not limited to:

1. Transient ischemic attack/stroke within 3 months of enrollment;
2. Significant congenital heart disease;
3. Uncontrolled hypertension;
4. Uncontrolled tachyarrhythmia led to symptoms or hemodynamic compromise.

• Participants required cardiac intervention (i.e., percutaneous coronaryintervention or coronary artery bypass graft) before completing the study.
• Primary hemodynamically significant uncorrected valvular heart disease,obstructive or regurgitant.
• Participants with screening laboratory findings as follows:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) wasgreater than 3 times the upper limit of normal;
2. Total bilirubin ≥2.0 mg/dL (34.2 μmol/L);
3. Serum creatinine ≥3.0 mg/dL (265.2 μmol/L).

• Participants who presented with any clinically active, serious, life-threateningdisease, medical or psychiatric condition, and/or who have a life expectancy of <6 months, or for whom study participation may compromise their management; andparticipants whom the investigator judges to be unsuitable for participation inthe study for any reason.
• Participants undergone evaluation for heart transplantation or with a history ofheart transplantation.
• Participants enrolled in another clinical study within the 30 days beforeenrollment in this study.
• Participants previously enrolled in this study or any Flurpiridaz (18F) Injectionstudy.