NCT01344447

Gadobutrol Enhanced MRA of the Supra-aortic Vessels

Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadovist, BAY86-4875)	A single bolus injection of approx. 0.1mmol/kg

Timeline

• Start date: 2011-05-12
• Primary completion: 2014-05-28
• Completion: 2014-05-28
• First posted: 2011-04-29
• Last updated: 2019-01-04
• Results posted: 2015-08-26

Locations

56 sites across 14 countries: United States, Argentina, Australia, Austria, China, Czechia, France, Germany, Italy, Poland, South Korea, Sweden, Switzerland, Turkey (Türkiye)