Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185276

Purpose

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist® (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist®, and with the results of your X-ray angiography.

Condition	Intervention	Phase
Peripheral Vascular Disease	Drug: Magnevist (Gadopentetate dimeglumine)	Phase III

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Gadolinium dtpa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Multi-Center Open Label Study of the Safety (Open-Label) and Efficacy (Open-Label & Blinded Reader) of Magnevist® Injection-Enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-Dimensional-Time-of-Flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-Arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference

Further study details as provided by Bayer:

Primary Outcome Measures:

Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease [ Time Frame: Image creation after injection - evaluation at blind read ]

Secondary Outcome Measures:

Diagnostic confidence [ Time Frame: At blinded or/and open label read of images ]
Visual assessment of stenosis [ Time Frame: At blinded or/and open label read of images ]
Difference in degree of stenosis [ Time Frame: At blinded or/and open label read of images ]
Other diagnostic findings [ Time Frame: At blinded or/and open label read of images ]
Image quality [ Time Frame: At blinded or/and open label read of images ]
Image evaluability and presence of artifacts [ Time Frame: At blinded or/and open label read of images ]
Ability to visualize arterial segments [ Time Frame: At blinded or/and open label read of images ]
Number of evaluable segments [ Time Frame: At blinded or/and open label read of images ]
Location and matching of stenosis [ Time Frame: At blinded or/and open label read of images ]
SI measurements [ Time Frame: At blinded or/and open label read of images ]
Patient management [ Time Frame: From baseline to 24 hours follow-up ]
Safety [ Time Frame: From baseline to 24 hours follow-up ]

Enrollment:	369
Study Start Date:	March 2003
Study Completion Date:	August 2004

Arms	Assigned Interventions
Arm 1: Experimental N/A	Drug: Magnevist (Gadopentetate dimeglumine) Single intravenous injection on the study day: lower dose corresponding approximately 0.1 mmol/kg body weight
Arm 2: Experimental N/A	Drug: Magnevist (Gadopentetate dimeglumine) Single intravenous injection on the study day: higher dose corresponding approximately 0.2 - 0.3 mmol/kg body weight

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has known or suspected peripheral vascular disease
Is scheduled for X-ray angiography

Exclusion Criteria:

Has any contraindication to magnetic resonance imaging
Is scheduled for any procedure before the X-ray angiography
Had previously had stents placed bilaterally in the region to be imaged

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185276

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	( Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head )
Study ID Numbers:	91208, 306781
Study First Received:	September 10, 2005
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00185276
Health Authority:	United States: Food and Drug Administration; Argentina: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Bayer:

Structural abnormalities of the infrarenal aorta and peripheral arteries
Peripheral vascular disease

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009