Gadobutrol Enhanced MRA of the Supra-aortic Vessels "GEMSAV"

Completed

Phase 3 Results

Update History

6 Jun '14
A location was updated in Tucson.
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The overall status was removed for Name Unavailable.
A location was updated in Newport Beach.
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The overall status was removed for Name Unavailable.
A location was updated in Jacksonville.
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The overall status was removed for Name Unavailable.
A location was updated in Savannah.
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The overall status was removed for Name Unavailable.
A location was updated in Louisville.
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The overall status was removed for Name Unavailable.
A location was updated in Baltimore.
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The overall status was removed for Name Unavailable.
A location was updated in Boston.
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The overall status was removed for Name Unavailable.
A location was updated in Boston.
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The overall status was removed for Name Unavailable.
A location was updated in Ann Arbor.
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The overall status was removed for Name Unavailable.
A location was updated in Jackson.
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The overall status was removed for Name Unavailable.
A location was updated in Bronx.
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The overall status was removed for Name Unavailable.
A location was updated in New York.
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The overall status was removed for Name Unavailable.
A location was updated in Rochester.
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The overall status was removed for Name Unavailable.
A location was updated in Cleveland.
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The overall status was removed for Name Unavailable.
A location was updated in Hershey.
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The overall status was removed for Name Unavailable.
A location was updated in Philadelphia.
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The overall status was removed for Name Unavailable.
A location was updated in Providence.
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The overall status was removed for Name Unavailable.
A location was updated in Memphis.
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The overall status was removed for Name Unavailable.
A location was updated in Seattle.
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The overall status was removed for Name Unavailable.
A location was updated in Madison.
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The overall status was removed for Name Unavailable.
A location was updated in Milwaukee.
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The overall status was removed for Name Unavailable.
A location was updated in Adrogué.
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The overall status was removed for Name Unavailable.
A location was updated in Buenos Aires.
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The overall status was removed for Name Unavailable.
A location was updated in Buenos Aires.
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The overall status was removed for Name Unavailable.
A location was updated in Rosario.
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The overall status was removed for Name Unavailable.
A location was updated in New Lambton Heights.
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The overall status was removed for Name Unavailable.
A location was updated in Bedford Park.
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The overall status was removed for Name Unavailable.
A location was updated in Clayton.
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The overall status was removed for Name Unavailable.
A location was updated in Parkville.
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The overall status was removed for Name Unavailable.
A location was updated in Innsbruck.
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The overall status was removed for Name Unavailable.
A location was updated in Wien.
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The overall status was removed for Name Unavailable.
A location was updated in Wiener Neustadt.
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The overall status was removed for Name Unavailable.
A location was updated in São Paulo.
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The overall status was removed for Name Unavailable.
A location was updated in Sao Paulo.
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The overall status was removed for Name Unavailable.
A location was updated in Sao Paulo.
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The overall status was removed for Name Unavailable.
A location was updated in Shanghai.
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The overall status was removed for Name Unavailable.
A location was updated in Shanghai.
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The overall status was removed for Name Unavailable.
A location was updated in Brno.
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The overall status was removed for Name Unavailable.
A location was updated in Plzen.
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The overall status was removed for Name Unavailable.
A location was updated in Praha 2.
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The overall status was removed for Name Unavailable.
A location was updated in Praha 5.
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The overall status was removed for Name Unavailable.
A location was updated in Brest Cedex.
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The overall status was removed for Name Unavailable.
A location was updated in BRON Cedex.
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The overall status was removed for Name Unavailable.
A location was updated in Marseille.
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The overall status was removed for Name Unavailable.
A location was updated in Paris.
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The overall status was removed for Name Unavailable.
A location was updated in Paris Cedex 15.
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The overall status was removed for Name Unavailable.
A location was updated in Karlsruhe.
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The overall status was removed for Name Unavailable.
A location was updated in Augsburg.
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The overall status was removed for Name Unavailable.
A location was updated in Erlangen.
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The overall status was removed for Name Unavailable.
A location was updated in Frankfurt.
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The overall status was removed for Name Unavailable.
A location was updated in Münster.
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The overall status was removed for Name Unavailable.
A location was updated in Kiel.
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The overall status was removed for Name Unavailable.
A location was updated in Jena.
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The overall status was removed for Name Unavailable.
A location was updated in Dresden.
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The overall status was removed for Name Unavailable.
A location was updated in Lagosanto.
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The overall status was removed for Name Unavailable.
A location was updated in Massa.
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The overall status was removed for Name Unavailable.
A location was updated in Mestre.
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The overall status was removed for Name Unavailable.
A location was updated in Aosta.
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The overall status was removed for Name Unavailable.
A location was updated in Catania.
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The overall status was removed for Name Unavailable.
A location was updated in Roma.
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The overall status was removed for Name Unavailable.
A location was updated in Donggu,.
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The overall status was removed for Name Unavailable.
A location was updated in Seoul.
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The overall status was removed for Name Unavailable.
A location was updated in Seoul.
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The overall status was removed for Name Unavailable.
A location was updated in Seoul.
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The overall status was removed for Name Unavailable.
A location was updated in Bydgoszcz.
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The overall status was removed for Name Unavailable.
A location was updated in Lodz.
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The overall status was removed for Name Unavailable.
A location was updated in Warszawa.
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The overall status was removed for Name Unavailable.
A location was updated in Wroclaw.
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The overall status was removed for Name Unavailable.
A location was updated in Zamosc.
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The overall status was removed for Name Unavailable.
A location was updated in Linköping.
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The overall status was removed for Name Unavailable.
A location was updated in Uppsala.
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The overall status was removed for Name Unavailable.
A location was updated in Aarau.
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The overall status was removed for Name Unavailable.
A location was updated in St. Gallen.
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The overall status was removed for Name Unavailable.
A location was updated in Bern.
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The overall status was removed for Name Unavailable.
A location was updated in Luzern.
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The overall status was removed for Name Unavailable.
A location was updated in Antalya.
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The overall status was removed for Name Unavailable.
A location was updated in Erzurum.
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The overall status was removed for Name Unavailable.
A location was updated in Istanbul.
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The overall status was removed for Name Unavailable.
2 May '14
A location was updated in Tucson.
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The overall status was removed for Name Unavailable.
A location was updated in Philadelphia.
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The overall status was removed for Name Unavailable.
A location was updated in Seattle.
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The overall status was removed for Name Unavailable.
A location was updated in Lagosanto.
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The overall status was removed for Name Unavailable.
A location was updated in Massa.
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The overall status was removed for Name Unavailable.
A location was updated in Mestre.
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The overall status was removed for Name Unavailable.
A location was updated in Aosta.
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The overall status was removed for Name Unavailable.
A location was updated in Roma.
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The overall status was removed for Name Unavailable.
A location was updated in Donggu,.
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The overall status was removed for Name Unavailable.
A location was updated in Seoul.
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The overall status was removed for Name Unavailable.
A location was updated in Seoul.
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The overall status was removed for Name Unavailable.
A location was updated in Seoul.
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The overall status was removed for Name Unavailable.
A location was updated in Linköping.
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The overall status was removed for Name Unavailable.
A location was updated in Uppsala.
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The overall status was removed for Name Unavailable.
3 Apr '14
A location was updated in Adrogué.
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The overall status was removed for Name Unavailable.
A location was updated in New Lambton Heights.
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The overall status was removed for Name Unavailable.
5 Mar '14
A location was updated in Buenos Aires.
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The overall status was removed for Name Unavailable.
A location was updated in Buenos Aires.
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The overall status was removed for Name Unavailable.
A location was updated in Paris Cedex 15.
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The overall status was removed for Name Unavailable.
5 Feb '14
A location was updated in Baltimore.
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The overall status was removed for Name Unavailable.
A location was updated in São Paulo.
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The overall status was removed for Name Unavailable.
A location was updated in Sao Paulo.
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The overall status was removed for Name Unavailable.
A location was updated in Sao Paulo.
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The overall status was removed for Name Unavailable.
8 Jan '14
A location was updated in Bronx.
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The overall status was removed for Name Unavailable.
A location was updated in Providence.
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The overall status was removed for Name Unavailable.
A location was updated in Madison.
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The overall status was removed for Name Unavailable.
13 Nov '13
A location was updated in Münster.
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The overall status was removed for Name Unavailable.
A location was updated in St. Gallen.
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The overall status was removed for Name Unavailable.
17 Oct '13
A location was updated in Jacksonville.
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The overall status was removed for Name Unavailable.
20 Aug '13
A location was updated in Shanghai.
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The overall status was removed for Name Unavailable.
A location was updated in Shanghai.
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The overall status was removed for Name Unavailable.
23 Jul '13
A location was updated in Innsbruck.
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The overall status was removed for Name Unavailable.
A location was updated in Wien.
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The overall status was removed for Name Unavailable.
25 May '13
A location was updated in Aarau.
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The overall status was removed for Name Unavailable.
A location was updated in St. Gallen.
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The overall status was removed for Name Unavailable.
24 Apr '13
The eligibility criteria were updated.
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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
Old
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 (Computed Tomographic Angiography [CTA] or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). [Note: Any CTA must meet the specifications provided in the protocol. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled.] - 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
8 Feb '13
A location was updated in Catania.
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The overall status was removed for Name Unavailable.
14 Dec '12
A location was updated in St. Gallen.
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The overall status was removed for Name Unavailable.
25 Jul '12
A location was updated in Louisville.
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The overall status was removed for Name Unavailable.
6 Jul '12
A location was updated in Bern.
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The overall status was removed for Name Unavailable.
7 Jun '12
A location was updated in Tucson.
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The overall status was removed for Name Unavailable.
A location was updated in Boston.
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The overall status was removed for Name Unavailable.
A location was updated in Bronx.
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The overall status was removed for Name Unavailable.
A location was updated in Milwaukee.
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The overall status was removed for Name Unavailable.
A location was updated in Luzern.
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The overall status was removed for Name Unavailable.
A location was updated in Istanbul.
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The overall status was removed for Name Unavailable.
2 May '12
A location was updated in Paris.
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The overall status was removed for Name Unavailable.
31 Mar '12
A location was updated in Cleveland.
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The overall status was removed for Name Unavailable.
A location was updated in Wiener Neustadt.
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The overall status was removed for Name Unavailable.
A location was updated in Frankfurt.
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The overall status was removed for Name Unavailable.
A location was updated in Erzurum.
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The overall status was removed for Name Unavailable.
7 Mar '12
A location was updated in Newport Beach.
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The overall status was removed for Name Unavailable.
A location was updated in Innsbruck.
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The overall status was removed for Name Unavailable.
A location was updated in Brest Cedex.
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The overall status was removed for Name Unavailable.
A location was updated in Karlsruhe.
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The overall status was removed for Name Unavailable.
A location was updated in Kiel.
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The overall status was removed for Name Unavailable.
A location was updated in Antalya.
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The overall status was removed for Name Unavailable.
8 Feb '12
A location was updated in Philadelphia.
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The overall status was removed for Name Unavailable.
A location was updated in Seattle.
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The overall status was removed for Name Unavailable.
A location was updated in Augsburg.
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The overall status was removed for Name Unavailable.
A location was updated in Dresden.
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The overall status was removed for Name Unavailable.
A location was updated in Linköping.
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The overall status was removed for Name Unavailable.
11 Jan '12
A location was updated in Louisville.
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The overall status was removed for Name Unavailable.
A location was updated in Rochester.
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The overall status was removed for Name Unavailable.
A location was updated in Providence.
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The overall status was removed for Name Unavailable.
A location was updated in Wien.
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The overall status was removed for Name Unavailable.
A location was updated in Praha 2.
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The overall status was removed for Name Unavailable.
A location was updated in Marseille.
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The overall status was removed for Name Unavailable.
A location was updated in Erlangen.
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The overall status was removed for Name Unavailable.
A location was updated in Jena.
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The overall status was removed for Name Unavailable.
A location was updated in Aosta.
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The overall status was removed for Name Unavailable.
9 Dec '11
A location was updated in Madison.
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The overall status was removed for Name Unavailable.
A location was updated in New Lambton Heights.
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The overall status was removed for Name Unavailable.
A location was updated in Mestre.
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The overall status was removed for Name Unavailable.
A location was updated in Wroclaw.
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The overall status was removed for Name Unavailable.
11 Nov '11
A location was updated in Boston.
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The overall status was removed for Name Unavailable.
A location was updated in Ann Arbor.
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The overall status was removed for Name Unavailable.
A location was updated in Parkville.
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The overall status was removed for Name Unavailable.
A location was updated in Lagosanto.
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The overall status was removed for Name Unavailable.
A location was updated in Zamosc.
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The overall status was removed for Name Unavailable.
A location was updated in Uppsala.
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The overall status was removed for Name Unavailable.
14 Oct '11
A location was updated in Boston.
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The overall status was removed for Name Unavailable.
A location was updated in Jackson.
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The overall status was removed for Name Unavailable.
A location was updated in Donggu,.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Warszawa.
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The overall status was removed for Name Unavailable.
6 Oct '11
The eligibility criteria were updated.
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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 (Computed Tomographic Angiography [CTA] or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). [Note: Any CTA must meet the specifications provided in the protocol. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled.] - 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
Old
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 (Computed Tomographic Angiography [CTA] or ultrasound) showing ? 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). [Note: Any CTA must meet the specifications provided in the protocol. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled.] - 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