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

Phase 3

Completed

• Conditions: Stenosis
• Interventions: Drug: Gadopentetate dimeglumine (Magnevist)

• Registration Number: NCT00309075
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2003-12
• Study Completion: 2004-11
• Study First Submitted: 2006-03-30
• Study First Submitted QC: 2006-03-30
• Study First Posted: 2006-03-31
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Gadopentetate dimeglumine (Magnevist)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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