Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

Randomized, Multi-center Open Label Study of the Safety (Open-label) and Efficacy (Open-label & Blinded Reader) of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185276

Enrollment

365

Registered

2005-09-16

Start date

2003-03-31

Completion date

2004-08-31

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

Peripheral Vascular Disease

Keywords

Structural abnormalities of the infrarenal aorta and peripheral 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 infrarenal aorta and peripheral 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, BAY86-4882)

Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Has known or suspected peripheral vascular 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

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease	Image creation after injection - evaluation at blind read

Secondary

Measure	Time frame
Ability to visualize arterial segments	At blinded or/and open label read of images
Number of evaluable segments	At blinded or/and open label read of images
Location and matching of stenosis	At blinded or/and open label read of images
SI measurements	At blinded or/and open label read of images
Patient management	From baseline to 24 hours follow-up
Image evaluability and presence of artifacts	At blinded or/and open label read of images
Diagnostic confidence	At blinded or/and open label read of images
Visual assessment of stenosis	At blinded or/and open label read of images
Difference in degree of stenosis	At blinded or/and open label read of images
Other diagnostic findings	At blinded or/and open label read of images
Image quality	At blinded or/and open label read of images
Safety	From baseline to 24 hours follow-up

Outcome results

None listed

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