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

Bayer126 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

126

Conditions

Stenosis

Interventions

Gadopentetate dimeglumine (Magnevist)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader

Time frame: Image creation after injection - evaluation at blind read