A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients with Suspected Vascular Disease
Phase 3 – large-scale trial before approval
Conditions:
Suspected Vascular Disease of supra-aortic (carotid/vertebrobasilar)
peripheral or abdominal/renal arteries
Sponsor: Guerbet, Bracco Imaging S.p.A.
trial.available_in:
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Overview
Trial status: Authorised
Diagnostic performance indicators, namely sensitivity and specificity for detecting clinically significant steno-occlusive disease of different vascular territories.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 300 participants
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