Gadobutrol Enhanced MRA of the Supra-aortic Vessels
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis
Intervention: Gadobutrol (Gadovist, BAY86-4875)
Intervention description: A single bolus injection of approx. 0.1mmol/kg
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 479.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Supra-aortic vascular disease; MRA; CTA; Males and females aged 18 years or older; Stroke; Transient Ischemic Attack (TIA)

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, aged 18 years and older

          -  Any of the following:

               -  Known or suspected supra-aortic arterial disease based on:

                    -  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 ≥ 50% stenosis of a supra-aortic
                  vessel segment (within 60 days before consent). The proportion of subjects with
                  positive disease (determined by the investigator, based on CTA or ultrasound)
                  will be monitored during the study, and enrolment may be further restricted to
                  require ≥ 70% stenosis to ensure that overall there are an adequate number of
                  subjects with clinically significant disease for the evaluation of study
                  endpoints.

          -  Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography
             [CE MRA] examination with gadobutrol

          -  Willingness and ability to follow directions and complete all study procedures
             specified in the protocol

          -  Females of childbearing potential only: Negative pregnancy test on the day of the MRA
             before the administration of study drug

        Exclusion Criteria:

          -  Pregnant or nursing (including pumping for storage and feeding)

          -  Received any other investigational product or participation in any other clinical
             trial within 30 days before enrollment into this study

          -  Previous enrollment into this study or into any other Bayer sponsored study using
             gadobutrol

          -  Contraindication to the MRA examinations (e.g. inability to hold breath; severe
             arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other
             metallic devices not approved for MRI)

          -  Contraindication to the use of Gd-containing contrast agents (including subjects with
             suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])

          -  History of severe allergic or anaphylactoid reaction to any allergen including drugs
             and contrast agents

          -  Received any contrast agent within 72 hours before the study MRA, or scheduled receipt
             of any contrast agent within 24 hours after the study MRA (Note: This applies also to
             a CTA potentially scheduled during the course of the study.)

          -  Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a
             serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on
             hemodialysis or peritoneal dialysis is excluded from participation. Use the value
             obtained prior to and closest to the time of the MRA, if there are multiple creatinine
             values. (Do not use the core lab value if not available prior to the MRA.)

          -  Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or
             occurring in the peri-operative liver transplantation period

          -  Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable
             angina, congestive heart failure New York Heart Association class IV) or known long QT
             syndrome

          -  Suspected clinical instability or unpredictability of the clinical course during the
             study period (e.g. due to previous surgery)

          -  Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:

               -  Any procedure that may alter the MRA or CTA interpretation, or

               -  Any interventional or surgical procedure involving the supra-aortic vessels