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 Aortic Arch and Cerebral Branches Who Are Undergoing MRA of These Vessels With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference.

Bayer0 sites123 target enrollmentDecember 2003

ConditionsCardiovascular Abnormalities

InterventionsGadopentetate dimeglumine (Magnevist)

DrugsGadopentetate dimeglumine (Magnevist)

Overview

Phase: Phase 3
Intervention: Gadopentetate dimeglumine (Magnevist)
Conditions: Cardiovascular Abnormalities
Sponsor: Bayer
Enrollment: 123
Primary Endpoint: Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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 aortic arch and cerebral branches. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

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.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

October 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has known or suspected disease of the aortic arch and cerebral branches
•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 previous bilateral intervention (surgery, bypass) of the arteries of interest

Arms & Interventions

Arm 1

Intervention: Gadopentetate dimeglumine (Magnevist)

Outcomes

Primary Outcomes

Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader

Time Frame: Image creation after injection -evaluation at blind read

Secondary Outcomes

Diagnostic confidence(At blinded and/or open label read of the images)
Visual assessment of stenosis(At blinded and/or open label read of the images)
Difference in degree of stenosis(At blinded and/or open label read of the images)
Other diagnostic findings(At blinded and/or open label read of the images)
Location and matching of stenosis(At blinded and/or open label read of the images)
Image quality(At blinded and/or open label read of the images)
Image evaluability and presence of artifacts(At blinded and/or open label read of the images)
Ability to visualize arterial segments(At blinded and/or open label read of the images)
Number of evaluable segments(At blinded and/or open label read of the images)
Duration if 2D TOF and CE-MRA(At blinded and/or open label read of the images)
Patient management(From baseline to 24 hours follow-up)
Safety variables(From baseline to 24 hours follow-up)
Proportion of correctly categorized maximum stenosis per segment(At blinded and/or open label read of the images)