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

Bayer

Status and phase: Completed; Phase 3

Conditions: Peripheral Vascular Disease

Treatments: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185276

91208

306781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 2

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)