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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2016

At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Carotid stenosis; Vascular disorders
  • Focus Diagnostic use; Registrational
  • Acronyms GEMSAV
  • Sponsors Bayer
  • Most Recent Events

    • 06 May 2016 New trial record
    • 29 Apr 2016 Primary endpoint has been met. (Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA)
    • 29 Apr 2016 Primary endpoint has been met. (Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA)
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