Study of XTR004 Injection for Detecting Blood Flow Blockages in Stable Coronary Artery Disease Patients Using PET Imaging Compared to Standard Angiography and Flow Reserve Tests

What this Trial Is About

Researchers are evaluating the effectiveness of XTR004 PET myocardial perfusion imaging MPI for detecting restrictive blood flow problems in patients with suspected or known stable coronary artery disease. This study compares XTR004 PET MPI with quantitative coronary angiography QCA and fractional flow reserve FFR as reference standards to see how well it detects restrictive stenosis. The trial is a multicenter, open-label, phase III clinical study sponsored by Sinotau Pharmaceutical Group. Participants will receive XTR004 as the experimental drug and undergo PET MPI scanning. The study also compares XTR004 PET MPI with MIBI SPECT MPI to evaluate differences in diagnostic accuracy, image quality, and certainty. The process includes using coronary artery angiography as a reference standard. Data will be collected over a 60-day assessment period to analyze diagnostic performance and safety. During the study, participants will undergo imaging tests including XTR004 PET MPI, MIBI SPECT MPI, and coronary angiography. Researchers will monitor diagnostic efficacy, image quality, and any treatment-related adverse events. Participants will be observed for up to 60 days to assess outcomes and safety. The study includes adults aged 18 to 80 years with suspected or confirmed stable coronary artery disease, and participation involves signing informed consent and complying with study requirements.

Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)