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RECRUITING
NCT07439133
PHASE3

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

Sponsor: Sinotau Pharmaceutical Group

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

395

Start Date

2025-11-14

Completion Date

2027-10

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

XTR004

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