RecruitingPhase 3NCT07439133

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


Sponsor

Sinotau Pharmaceutical Group

Enrollment

395 participants

Start Date

Nov 14, 2025

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called XTR004 for people with coronary artery disease (cad). The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 80 Years.

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

DRUGXTR004

XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard


Locations(5)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Beijing Tongren Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The First People's Hospital of Foshan

Foshan, China

TEDA International Cardiovascular Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07439133


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