Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
Evaluation of the Efficacy and Safety of XTR004 Injection in Detecting Blood Flow Restrictive Stenosis in Patients With Suspected or Known Stable Coronary Artery Disease: A Multicenter, Open-Label, Phase III Clinical Trial
Sinotau Pharmaceutical Group
395 participants
Nov 14, 2025
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard
Locations(5)
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NCT07439133