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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309075

Enrollment

126

Registered

2006-03-31

Start date

2003-12-31

Completion date

2004-11-30

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosis

Keywords

Stenosis of the calf and/or pedal arteries

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.

Interventions

DRUGGadopentetate dimeglumine (Magnevist)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Duration of 2D-TOF and MRA	At blinded and/or open label read of the images
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
Number of evaluable arteries	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
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 evaluability and presence of artefacts	At blinded and/or open label read of the images

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026