Trials / Recruiting
RecruitingNCT07439133
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 395 (estimated)
- Sponsor
- Sinotau Pharmaceutical Group · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XTR004 | XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard |
Timeline
- Start date
- 2025-11-14
- Primary completion
- 2027-06-01
- Completion
- 2027-10-01
- First posted
- 2026-02-27
- Last updated
- 2026-03-03
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07439133. Inclusion in this directory is not an endorsement.