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

Recruiting Phase 3 Interventional Study
Coronary Artery Disease(CAD)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
395 (estimated)
Sponsor
Sinotau Pharmaceutical Group · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants aged 18 to 80 years, male or female. * Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes, obesity…
Contacts

LING YUAN

010-80716990

ling.yuan@sinotau.com

CONTACT