Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-12-31

Brief Summary

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To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

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Detailed Description

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Conditions

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Carotid, Aortic, Renal or Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MultiHance contrast agent

MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)

Group Type EXPERIMENTAL

Gadobenate Dimeglumine

Intervention Type DRUG

0.1 mmol/kg, single dose

Magnevist

Magnevist administered at a dose of 0.2 mmol/kg

Group Type ACTIVE_COMPARATOR

Gadopentetate Dimeglumine

Intervention Type DRUG

Double dose of 0.2 mmol/kg

Interventions

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Gadobenate Dimeglumine

0.1 mmol/kg, single dose

Intervention Type DRUG

Gadopentetate Dimeglumine

Double dose of 0.2 mmol/kg

Intervention Type DRUG

Other Intervention Names

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MultiHance Magnevist

Eligibility Criteria

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Inclusion Criteria

* 18 yrs of age or older
* referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
* Able to provide written informed consent and comply with protocol requirements
* Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol

Exclusion Criteria

* pregnant or lactating females
* Known allergy to one or more of the ingredients in the products under investigation
* Significant congestive heart failure ( Class IV)
* Moderate to severe chronic kidney disease
* Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
* Vascular stents in vessels of interest
* Received another contrast agent in the 24 hrs preceding or proceeding each exam
* Previously entered into the study
* Contraindications to MRI
* Severe Claustrophobia Undergone DSA between the two exams

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No