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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:
NCT01010932
First received: November 9, 2009
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.


Condition Intervention Phase
Carotid or Vertebral Arterial Disease
 Drug: Dotarem
Other: TOF MRA
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Measurement of carotid and vertebral artery stenosis [ Time Frame: 0 - 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 222
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dotarem and TOF MRA
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010932

Locations
United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01010932     History of Changes
Other Study ID Numbers: DGD-44-048
Study First Received: November 9, 2009
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Guerbet:
carotid or vertebral artery disease
Contrast agent
MRA

ClinicalTrials.gov processed this record on June 18, 2013