Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease - Full Text View

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:

MedlinePlus related topics: Peripheral Arterial Disease

Drug Information available for: Gadoterate meglumine Gadobutrol

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases	Vascular Diseases Gadobutrol Gadoterate meglumine Contrast Media Diagnostic Uses of Chemicals Pharmacologic Actions

ClinicalTrials.gov processed this record on February 27, 2015

Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease (DALIA)