Gadobutrol Enhanced MRA of the Supra-aortic Vessels

Last updated: December 10, 2018
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Carotid Artery Disease

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01344447
14607
2010-023001-36
  • Ages > 18
  • All Genders

Study 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

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 significantstenosis)

  • Follow-up for a stent in a supra-aortic vessel

  • Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aorticvessel segment (within 60 days before consent). The proportion of subjects withpositive disease (determined by the investigator, based on CTA or ultrasound)will be monitored during the study, and enrolment may be further restricted torequire ≥ 70% stenosis to ensure that overall there are an adequate number ofsubjects with clinically significant disease for the evaluation of studyendpoints.

  • 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 proceduresspecified in the protocol

  • Females of childbearing potential only: Negative pregnancy test on the day of the MRAbefore the administration of study drug

Exclusion

Exclusion Criteria:

  • Pregnant or nursing (including pumping for storage and feeding)

  • Received any other investigational product or participation in any other clinicaltrial within 30 days before enrollment into this study

  • Previous enrollment into this study or into any other Bayer sponsored study usinggadobutrol

  • Contraindication to the MRA examinations (e.g. inability to hold breath; severearrhythmias; very low cardiac output, severe claustrophobia, defibrillators or othermetallic devices not approved for MRI)

  • Contraindication to the use of Gd-containing contrast agents (including subjects withsuspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])

  • History of severe allergic or anaphylactoid reaction to any allergen including drugsand contrast agents

  • Received any contrast agent within 72 hours before the study MRA, or scheduled receiptof any contrast agent within 24 hours after the study MRA (Note: This applies also toa CTA potentially scheduled during the course of the study.)

  • Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from aserum creatinine result within 2 weeks before the gadobutrol injection. Any subject onhemodialysis or peritoneal dialysis is excluded from participation. Use the valueobtained prior to and closest to the time of the MRA, if there are multiple creatininevalues. (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 oroccurring in the peri-operative liver transplantation period

  • Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstableangina, congestive heart failure New York Heart Association class IV) or known long QTsyndrome

  • Suspected clinical instability or unpredictability of the clinical course during thestudy 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

Study Design

Total Participants: 479
Study Start date:
May 12, 2011
Estimated Completion Date:
May 28, 2014

Connect with a study center

  • Adrogué, Buenos Aires B1846DWA
    Argentina

    Site Not Available

  • Buenos Aires, Ciudad Auton. De Buenos Aires C1425BEE
    Argentina

    Site Not Available

  • empty

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • New Lambton Heights, New South Wales 2305
    Australia

    Site Not Available

  • empty

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Clayton, Victoria 3168
    Australia

    Site Not Available

  • Parkville, Victoria 3052
    Australia

    Site Not Available

  • Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Wien, 1090
    Austria

    Site Not Available

  • empty

    Wiener Neustadt, 2700
    Austria

    Site Not Available

  • empty

    São Paulo, Sao Paulo 05651-900
    Brazil

    Site Not Available

  • empty

    Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • Shanghai, 200433
    China

    Site Not Available

  • empty

    Plzen, 304 60
    Czech Republic

    Site Not Available

  • empty

    Praha 2, 128 21
    Czech Republic

    Site Not Available

  • empty

    Praha 5, 150 00
    Czech Republic

    Site Not Available

  • Brno, 62500
    Czechia

    Site Not Available

  • BRON Cedex, 69677
    France

    Site Not Available

  • Brest Cedex, 29609
    France

    Site Not Available

  • Marseille, 13385
    France

    Site Not Available

  • Paris, 75877
    France

    Site Not Available

  • Paris Cedex 15, 75908
    France

    Site Not Available

  • Karlsruhe, Baden-Württemberg 76133
    Germany

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  • Augsburg, Bayern 865156
    Germany

    Site Not Available

  • Erlangen, Bayern 91054
    Germany

    Site Not Available

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    Frankfurt, Hessen 60596
    Germany

    Site Not Available

  • Münster, Nordrhein-Westfalen 48145
    Germany

    Site Not Available

  • empty

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Jena, Thüringen 07740
    Germany

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  • empty

    Dresden, 01307
    Germany

    Site Not Available

  • Ferrara, Emilia-Romagna 44023
    Italy

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  • empty

    Lagosanto, Ferrara 44023
    Italy

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  • Roma, Lazio 00168
    Italy

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  • Catania, Sicilia 95123
    Italy

    Site Not Available

  • Massa-Carrara, Toscana 54100
    Italy

    Site Not Available

  • Aosta, Valle d'Aosta 11100
    Italy

    Site Not Available

  • Venezia, Veneto 30174
    Italy

    Site Not Available

  • empty

    Mestre, Venezia 30174
    Italy

    Site Not Available

  • empty

    Massa, 54100
    Italy

    Site Not Available

  • Donggu,, Gwangju Gwang''yeogsi 61469
    Korea, Republic of

    Site Not Available

  • Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Lodz, 90-153
    Poland

    Site Not Available

  • Warszawa, 02-097
    Poland

    Site Not Available

  • Wroclaw, 50-556
    Poland

    Site Not Available

  • empty

    Zamosc, 22-400
    Poland

    Site Not Available

  • empty

    Linköping, 581 85
    Sweden

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  • Linköping, 581 85
    Sweden

    Site Not Available

  • Uppsala, 751 85
    Sweden

    Site Not Available

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    Aarau, Aargau 5001
    Switzerland

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  • St. Gallen, Sankt Gallen 9007
    Switzerland

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  • empty

    Bern, 3010
    Switzerland

    Site Not Available

  • empty

    Luzern, 6000
    Switzerland

    Site Not Available

  • Antalya, 07059
    Turkey

    Site Not Available

  • Erzurum, 25240
    Turkey

    Site Not Available

  • Istanbul, 34093
    Turkey

    Site Not Available

  • Tucson, Arizona 85724
    United States

    Site Not Available

  • empty

    Newport Beach, California 92658-6100
    United States

    Site Not Available

  • Jacksonville, Florida 32209
    United States

    Site Not Available

  • Savannah, Georgia 31406
    United States

    Site Not Available

  • Louisville, Kentucky 40202
    United States

    Site Not Available

  • Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ann Arbor, Michigan 48109-0330
    United States

    Site Not Available

  • Jackson, Mississippi 39216
    United States

    Site Not Available

  • Bronx, New York 10467
    United States

    Site Not Available

  • empty

    New York, New York 10032
    United States

    Site Not Available

  • Rochester, New York 14642
    United States

    Site Not Available

  • empty

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • empty

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19104
    United States

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  • Providence, Rhode Island 02903
    United States

    Site Not Available

  • Memphis, Tennessee 38104
    United States

    Site Not Available

  • Seattle, Washington 98195
    United States

    Site Not Available

  • Madison, Wisconsin 53792
    United States

    Site Not Available

  • empty

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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