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

Bayer

Status and phase: Completed; Phase 3

Conditions: Stenosis

Treatments: Drug: Gadopentetate dimeglumine (Magnevist)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309075

307260

91251

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 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.

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: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist)