Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease (DALIA)
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|ClinicalTrials.gov Identifier: NCT01026389|
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: Dotarem Drug: Gadovist||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||January 2012|
Active Comparator: Gadovist
Patient received contrast-enhanced MRA with Gadovist
Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus
Other Name: gadobutrol
Experimental: Dotarem, interventional
Patients received contrast-enhanced MRA with Dotarem
DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus
- Intra-patient Accuracy (Percent Agreement), On-site Data [ Time Frame: up to one month ]intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.
- Intra-patient Accuracy, in Off-site Readings [ Time Frame: up to one month ]• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion
- Specificity [ Time Frame: up to one month ]Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).
- Sensitivity [ Time Frame: up to one month ]sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026389