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DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases

NCT ID: NCT00955617

Last Updated: 2012-11-02

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-10-31

Brief Summary

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This study is an intra-individual comparison of DOTAREM®-enhanced MRA and 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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Dotarem Gadovist Peripheral arterial disease MRA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dotarem / Gadovist

Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2

Group Type EXPERIMENTAL

Contrast-enhanced MRA - Imaging examination

Intervention Type OTHER

Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)

Gadovist / Dotarem

Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2

Group Type EXPERIMENTAL

Contrast-enhanced MRA - Imaging examination

Intervention Type OTHER

Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)

Interventions

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Contrast-enhanced MRA - Imaging examination

Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)

Intervention Type OTHER

Other Intervention Names

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Dotarem-enhanced MRA Gadovist-enhanced MRA

Eligibility Criteria

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Inclusion Criteria

* Female or male, aged ≥ 18 years
* Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.

Exclusion Criteria

* Patients with severely impaired renal function with an eGFR (MDRD) \< 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
* Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
* Patient who had a major cardiovascular event within 30 days prior to the inclusion.
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

Principal Investigators

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Guerbet

Role: STUDY_DIRECTOR

Guerbet

Locations

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Guerbet

Roissy CDG, , France

Site Status

Countries

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France

Other Identifiers

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DGD-44-052

Identifier Type: -

Identifier Source: org_study_id