Phase 3
N=222
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Cerebral Arterial Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01010932 ↗Enrolled (actual)
222
Serious AEs
0.6%
Results posted
Aug 2015
Primary outcome: Primary: Technical Failure Rate — 4.65; 29.44; 1.77; 16.70 percentage of arterial segments
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dotarem (Drug); TOF MRA (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Failure Rate |
4.65; 29.44; 1.77; 16.70; 2.20; 18.54 | — |
| PRIMARY Sensitivity |
58.46; 53.85; 63.08; 63.08; 53.85; 49.23 | — |
| PRIMARY Specificity |
98.13; 85.43; 98.51; 90.39; 98.63; 90.42 | — |
Summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01010932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.