Conditions: Carotid Stenosis
Keywords: Supra-aortic vascular disease MRA CTA Males and females aged 18 years or older Stroke Transient Ischemic Attack (TIA)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 479
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Gadobutrol (Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: A single bolus injection of approx. 0.1mmol/kg

Protocol document: