drugset / Trial / NCT01344447

Gadobutrol Enhanced MRA of the Supra-aortic Vessels

NCT01344447

Phase 3 Completed 479 enrolled Bayer
NaSingle-groupOpen-labelDiagnostic

Summary

Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study. MRA and CTA images will be collected for an independent review (blinded read).

Timeline

Start
2011-05-12
Primary completion
2014-05-28
Completion
2014-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobutrol Diagnostic / imaging agent 0.1 unknown Intravenous

Indications