drugset / Trial / NCT07439133

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

NCT07439133

Phase 3 Recruiting 395 enrolled Sinotau Pharmaceutical Group
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2025-11-14
Primary completion
2027-06
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject 99mTechnetium Sestamibi Unknown
Subject XTR004 Diagnostic / imaging agent