Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00309075

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 calf and foot 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
Stenosis	Drug: Gadopentetate dimeglumine (Magnevist® Injection)	Phase III

MedlinePlus related topics: Foot Health

Drug Information available for: Gadolinium dtpa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Open-Label Study of the Safety (Open-Label) and Efficacy (Open-Label and Blinded Reader) of a Single Administration of Approximately 0.1 Mmol/kg of Magnevist® Injection-Enhanced Magnetic Resonance Arteriography (MRA) and 2-Dimensional-Time-of-Flight (2D-TOF) MRA in Patients With Known or Suspected Disease of the Calf and/or Pedal Arteries Undergoing MRA of the Calf and Pedal Arteries With Intra-Arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference.

Further study details as provided by Bayer:

Primary Outcome Measures:

Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader [ Time Frame: Image creation after injection - evaluation at blind read ]

Secondary Outcome Measures:

Diagnostic confidence [ Time Frame: At blinded and/or open label read of the images ]
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader [ Time Frame: At blinded and/or open label read of the images ]
Location and matching of stenosis [ Time Frame: At blinded and/or open label read of the images ]
Image quality [ Time Frame: At blinded and/or open label read of the images ]
Image evaluability and presence of artefacts [ Time Frame: At blinded and/or open label read of the images ]
Ability to visualize arteries [ Time Frame: At blinded and/or open label read of the images ]
Exact categorization of stenosis [ Time Frame: At blinded and/or open label read of the images ]
Number of evaluable arteries [ Time Frame: At blinded and/or open label read of the images ]
Duration of 2D-TOF and MRA [ Time Frame: At blinded and/or open label read of the images ]
Artery appropriate for bypass [ Time Frame: At blinded and/or open label read of the images ]
Patient management [ Time Frame: from baseline to 24 hours follow-up ]
Safety [ Time Frame: from baseline to 24 hours follow-up ]

Enrollment:	127
Study Start Date:	December 2003
Study Completion Date:	November 2004

Arms	Assigned Interventions
Arm 1: Experimental N/A	Drug: Gadopentetate dimeglumine (Magnevist® Injection) Gadopentetate dimeglumine (Magnevist® Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

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 disease of the calf and/or pedal arteries
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 calf and/or foot arteries

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309075

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:	91251, 307260
Study First Received:	March 30, 2006
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00309075
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health; Canada: Health Canada; Chile: Ministry of Health (ISP); Mexico: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Bayer:

Stenosis of the calf and/or pedal arteries

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Constriction, Pathologic

ClinicalTrials.gov processed this record on January 14, 2009