Trial Condition(s):

Carotid stenosis

Gadobutrol enhanced MRA of the supra-aortic vessels (GEMSAV)

Bayer Identifier:

14607

ClinicalTrials.gov Identifier:

NCT01344447

EudraCT Number:

2010-023001-36

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
479
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

St. Gallen, Switzerland, 9007

Status
Completed
 
Locations

Investigative Site

Karlsruhe, Germany, 76133

Status
Completed
 
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Investigative Site

Augsburg, Germany, 865156

Status
Completed
 
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Investigative Site

Jena, Germany, 07740

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
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Investigative Site

Louisville, United States, 40202

Status
Completed
 
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Investigative Site

Savannah, United States, 31406

Status
Completed
 
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Investigative Site

Jackson, United States, 39216

Status
Completed
 
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Investigative Site

Bronx, United States, 10467

Status
Completed
 
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Investigative Site

Seattle, United States, 98195

Status
Completed
 
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Investigative Site

Madison, United States, 53792

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
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Investigative Site

BRON Cedex, France, 69677

Status
Completed
 
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Investigative Site

Marseille, France, 13385

Status
Completed
 
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Investigative Site

PARIS, France, 75877

Status
Completed
 
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Investigative Site

Warszawa, Poland, 02-097

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 50-556

Status
Completed
 
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Investigative Site

Bydgoszcz, Poland, 85-094

Status
Completed
 
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Investigative Site

Lodz, Poland, 90-153

Status
Completed
 
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Investigative Site

Massa-Carrara, Italy, 54100

Status
Completed
 
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Investigative Site

Ferrara, Italy, 44023

Status
Completed
 
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Investigative Site

Catania, Italy, 95123

Status
Completed
 
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Investigative Site

Roma, Italy, 00168

Status
Completed
 
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Investigative Site

Venezia, Italy, 30174

Status
Completed
 
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Investigative Site

Uppsala, Sweden, 751 85

Status
Completed
 
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Investigative Site

Linköping, Sweden, 581 85

Status
Completed
 
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Investigative Site

Brno, Czech Republic, 62500

Status
Completed
 
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Investigative Site

Clayton, Australia, 3168

Status
Completed
 
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Investigative Site

Parkville, Australia, 3052

Status
Completed
 
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Investigative Site

New Lambton Heights, Australia, 2305

Status
Completed
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
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Investigative Site

Istanbul, Turkey, 34093

Status
Completed
 
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Investigative Site

Erzurum, Turkey, 25240

Status
Completed
 
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Investigative Site

Antalya, Turkey, 07059

Status
Completed
 
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Investigative Site

Seoul, South Korea, 06351

Status
Completed
 
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Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
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Investigative Site

Donggu,, South Korea, 61469

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03722

Status
Completed
 
Locations

Investigative Site

Aosta, Italy, 11100

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02114

Status
Completed
 
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Investigative Site

Rochester, United States, 14642

Status
Completed
 
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Investigative Site

Memphis, United States, 38104

Status
Completed
 
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Investigative Site

Providence, United States, 02903

Status
Completed
 
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Investigative Site

Tucson, United States, 85724

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109-0330

Status
Completed
 
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Investigative Site

Shanghai, China, 200032

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200433

Status
Completed
 
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Investigative Site

BREST CEDEX, France, 29609

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21201

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32209

Status
Completed
 
Locations

Investigative Site

Münster, Germany, 48145

Status
Completed
 
Locations

Investigative Site

Adrogué, Argentina, B1846DWA

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1115AAB

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1425BEE

Status
Completed
 
Locations

Investigative Site

PARIS CEDEX 15, France, 75908

Status
Completed
 

Trial Design