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

NCT ID: NCT01026389

Last Updated: 2012-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-01-31

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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Keywords

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MRA-Contrast agent comparison in peripheral disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gadovist

Patient received contrast-enhanced MRA with Gadovist

Group Type ACTIVE_COMPARATOR

Gadovist

Intervention Type DRUG

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

Dotarem, interventional

Patients received contrast-enhanced MRA with Dotarem

Group Type EXPERIMENTAL

Dotarem

Intervention Type DRUG

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

Interventions

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Dotarem

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

Intervention Type DRUG

Gadovist

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

Intervention Type DRUG

Other Intervention Names

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gadoterate Gd-Dota gadobutrol

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AKH hospital

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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DGD 44-045

Identifier Type: -

Identifier Source: org_study_id