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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

December 3, 2009
November 14, 2012
October 2009
June 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01026389 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Peripheral Arterial Disease
  • Drug: Dotarem
    DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus
    Other Names:
    • gadoterate
    • Gd-Dota
  • Drug: Gadovist
    Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus
    Other Name: gadobutrol
  • Active Comparator: Gadovist
    Patient received contrast-enhanced MRA with Gadovist
    Intervention: Drug: Gadovist
  • Experimental: Dotarem, interventional
    Patients received contrast-enhanced MRA with Dotarem
    Intervention: Drug: Dotarem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
January 2012
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01026389
DGD 44-045
No
Guerbet
Guerbet
Not Provided
Not Provided
Guerbet
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP