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

Guerbet189 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

189

Conditions

Peripheral Arterial Disease

Interventions

DotaremDRUG

DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus

GadovistDRUG

Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

AKH hospital

Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: up to one month

Secondary Outcomes

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

Time frame: 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).

Time frame: 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).

Time frame: up to one month

Data from ClinicalTrials.gov

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