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

NCT07439133 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Coronary Artery Disease(CAD)

Interventions

DRUG

XTR004

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

Sponsors & Collaborators

  • Sinotau Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2027-06-30
Completion
2027-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07439133 on ClinicalTrials.gov