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Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease (DALIA)
This study has been completed.
Sponsor:
Guerbet
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01026389
First received: December 3, 2009
Last updated: November 14, 2012
Last verified: November 2012
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Purpose
This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
| Condition | Intervention | Phase |
|---|---|---|
| Peripheral Arterial Disease | Drug: Dotarem Drug: Gadovist | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Guerbet:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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).
| Enrollment: | 189 |
| Study Start Date: | October 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Gadovist
Patient received contrast-enhanced MRA with Gadovist
|
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
|
Drug: Dotarem
DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01026389
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026389
Locations
| Austria | |
| AKH hospital | |
| Wien, Austria | |
Sponsors and Collaborators
Guerbet
More Information
| Responsible Party: | Guerbet |
| ClinicalTrials.gov Identifier: | NCT01026389 History of Changes |
| Other Study ID Numbers: |
DGD 44-045 |
| Study First Received: | December 3, 2009 |
| Results First Received: | November 14, 2012 |
| Last Updated: | November 14, 2012 |
Keywords provided by Guerbet:
|
MRA-Contrast agent comparison in peripheral disease |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on July 21, 2017