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 Renal Artery Disease Undergoing MRA of the Renal Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference

Bayer0 sites116 target enrollmentDecember 2003

ConditionsRenal Artery Stenosis

InterventionsGadopentetate dimeglumine (Magnevist)

DrugsGadopentetate dimeglumine (Magnevist)

Overview

Phase: Phase 3
Intervention: Gadopentetate dimeglumine (Magnevist)
Conditions: Renal Artery Stenosis
Sponsor: Bayer
Enrollment: 116
Primary Endpoint: Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
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 renal arteries. 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

December 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 renal artery 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

Arms & Interventions

Arm 1

Intervention: Gadopentetate dimeglumine (Magnevist)

Outcomes

Primary Outcomes

Accuracy, sensitivity and specificity based on quantitative assessment of stenosis

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

Secondary Outcomes

Localisation matching of maximum stenosis(At blinded and/or open label read of images)
Number of evaluable arteries(At blinded and/or open label read of images)
Patient management(From baseline to 24 hours follow-up)
Difference in degree of stenosis(At blinded and/or open label read of images)
Image evaluability and presence of artifacts(At blinded and/or open label read of images)
Other diagnostic findings(At blinded and/or open label read of images)
Image quality(At blinded and/or open label read of images)
Safety(From baseline to 24 hours follow-up)
Diagnostic confidence(At blinded and/or open label read of images)
Proportions of correctly categorised arteries with regard to maximum stenosis(At blinded and/or open label read of images)
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses(At blinded and/or open label read of images)