Trial Information

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

The purpose of this study is to look at the efficacy (how well it works) and safety (what are the side effects) of gadobutrol when used for taking MR images of the supra-aortic vessels. The main goal is to compare the diagnostic results of MRA images obtained before and after giving the contrast agent gadobutrol with those of a CTA that has been performed up to 60 days before enrollment in this study

Patient Inclusion Criteria:

Male or female subjects at least 18 years of age
Has known or suspected supra-aortic arterial disease based on any of the following:
- Prior stroke
- Transient ischemic attack (TIA)
- Amaurosis Fugax (transient monocular blindness)
- Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
- Follow-up for a stent in a supra-aortic vessel
- Prior imaging study (CTA or ultrasound) showing more than 50% stenosis of a supra-aortic vessel segment (within 60 days before consent)

Patient Inclusion Criteria:

Pregnant or nursing (including pumping for storage and feeding).
Contraindication to the MRA examinations
Contraindication to the use of Gd-containing contrast agents
History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents

James Fisher
Einstein-Montefiore Institute for Clinical & Translational Research
Department of Obstetrics and Gynecology and Women's Health
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-6642
Email: jamfishe@montefiore.org

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Research Center Information: Einstein-Montefiore Institute for Clinical & Translational Research

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