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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Drug: Dotarem
* Drug: Gadovist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gadovist<br>Patient received contrast-enhanced MRA with Gadovist | Drug: Gadovist<br>* Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus<br>* Other names: gadobutrol;|
| Experimental: Dotarem, interventional<br>Patients received contrast-enhanced MRA with Dotarem | Drug: Dotarem<br>* DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus<br>* Other names: Gd-Dota;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-patient Accuracy (Percent Agreement), On-site Data | 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. | up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-patient Accuracy, in Off-site Readings | • 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 | up to one month | 
| Specificity | 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). | up to one month | 
| Sensitivity | 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). | up to one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRA-Contrast agent comparison in peripheral disease