Phase 3
N=211
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Cerebral Arterial Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01012674 ↗Enrolled (actual)
211
Serious AEs
0.3%
Results posted
Aug 2015
Primary outcome: Primary: Technical Failure Rate — 3.55; 29.22; 1.57; 17.65 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 |
3.55; 29.22; 1.57; 17.65; 1.68; 23.07 | — |
| PRIMARY Sensitivity |
70.65; 65.22; 69.57; 73.91; 75.00; 66.30 | — |
| PRIMARY Specificity |
98.03; 84.34; 98.40; 89.51; 98.61; 88.40 | — |
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 (NCT01012674). 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.