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.

Bayer0 sites126 target enrollmentDecember 2003

ConditionsStenosis

InterventionsGadopentetate dimeglumine (Magnevist)

DrugsGadopentetate dimeglumine (Magnevist)

Overview

Phase: Phase 3
Intervention: Gadopentetate dimeglumine (Magnevist)
Conditions: Stenosis
Sponsor: Bayer
Enrollment: 126
Primary Endpoint: Accuracy, sensitivity, and specificity based on visual 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 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.

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

November 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 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

Arms & Interventions

Arm 1

Intervention: Gadopentetate dimeglumine (Magnevist)

Outcomes

Primary Outcomes

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 Outcomes

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