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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00309075

Collaborator

(none)

126

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stenosis	Drug: Gadopentetate dimeglumine (Magnevist)	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Study Start Date :

Dec 1, 2003

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Gadopentetate dimeglumine (Magnevist) Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Gadopentetate dimeglumine (Magnevist)

Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Outcome Measures

Primary Outcome Measures

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

Diagnostic confidence [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]
Image quality [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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00309075

Other Study ID Numbers:

91251
307260

First Posted:

Mar 31, 2006

Last Update Posted:

Dec 30, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Bayer

Stenosis of the calf and/or pedal arteries

Additional relevant MeSH terms:

Constriction, Pathologic

Study Results

No Results Posted as of Dec 30, 2014