Coronary Artery Disease (CAD) Clinical Trial
Official title:
Evaluation of XTR004 as a Novel 18F-labeled PET Myocardial Perfusion Imaging (MPI) Tracer in Diagnosis of Known or Suspected CAD Compared With Invasive Coronary Angiography, Fractional Flow Reserve, Index of Microcirculatory Resistance
The diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD and invasive pressure-temperature FFR/IMR as a reference for the detection of abnormal coronary function.
A phase II study that is single-arm, open-label, multi-center, and self-controlled with the following objectives; 1. Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD. 2. The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve (FFR), and index of microcirculation resistance (IMR) as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction. 3. Subjects' safety after two doses of XTR004 intravenous injection. ;
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