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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease | Drug: Dotarem Drug: Gadovist | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 189 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Gadovist
Patient received contrast-enhanced MRA with Gadovist
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Drug: 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
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Drug: Dotarem
DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus
Other Names:
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- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, aged ≥ 18 years.
- Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
- Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.
Exclusion Criteria:
- Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
- Patient who had a major cardiovascular event within 30 days prior to the inclusion.
- Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026389
Austria | |
AKH hospital | |
Wien, Austria |
Responsible Party: | Guerbet |
ClinicalTrials.gov Identifier: | NCT01026389 |
Other Study ID Numbers: |
DGD 44-045 |
First Posted: | December 4, 2009 Key Record Dates |
Results First Posted: | December 11, 2012 |
Last Update Posted: | December 11, 2012 |
Last Verified: | November 2012 |
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