Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guerbet

ClinicalTrials.gov Identifier:

NCT01012674

First received: November 12, 2009

Last updated: April 4, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 12, 2009
Last Updated Date	April 4, 2013
Start Date ^ICMJE	October 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 12, 2009)	Measurement of carotid and vertebral artery stenosis [ Time Frame: 0 - 14 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01012674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 12, 2009)	Blood sampling [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Tolerance at the injection site [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Adverse events [ Time Frame: 0 - 44 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Official Title ^ICMJE	Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease
Brief Summary	The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Carotid Arterial Disease Vertebral Arterial Disease
Intervention ^ICMJE	Drug: Dotarem Each subject will receive one injection of Dotarem 0.2ml/kg Other Name: Gadoterate meglumine Other: TOF MRA Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)
Study Arm (s)	Experimental: Dotarem and TOF MRA Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. Interventions: Drug: Dotarem Other: TOF MRA
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	211
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female, aged more than 18 years Strongly suspected of having carotid or vertebral arterial disease Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination Exclusion Criteria: Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²) Contraindication to MRI Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01012674
Other Study ID Numbers ^ICMJE	DGD-44-049
Has Data Monitoring Committee	No
Responsible Party	Guerbet
Study Sponsor ^ICMJE	Guerbet
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Guerbet
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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