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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:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01026389
First received: December 3, 2009
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Intra-patient Accuracy (Percent Agreement), On-site Data [ Time Frame: up to one month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • gadoterate
  • Gd-Dota

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026389

Locations
Austria
AKH hospital
Wien, Austria
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

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
Health Authority: Austria: Agency for Health and Food Safety
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Spain: Ministry of Health

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 May 19, 2013