Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

NCT ID: NCT01012674

Last Updated: 2016-06-16

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

PHASE3

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed Description

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Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA

Conditions

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Cerebral Arterial Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dotarem and TOF MRA

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Group Type EXPERIMENTAL

Dotarem

Intervention Type DRUG

Each subject will receive one injection of Dotarem 0.2ml/kg

TOF MRA

Intervention Type OTHER

Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)

Interventions

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Dotarem

Each subject will receive one injection of Dotarem 0.2ml/kg

Intervention Type DRUG

TOF MRA

Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)

Intervention Type OTHER

Other Intervention Names

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Gadoterate meglumine

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged more than 18 years
* Strongly suspected of having carotid or vertebral arterial disease
* Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Exclusion Criteria

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
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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Pierre DESCHE, MD

Role: STUDY_DIRECTOR

Guerbet

Locations

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Guerbet LLC

Bloomington, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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DGD-44-049

Identifier Type: -

Identifier Source: org_study_id

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