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

Bayer365 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 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.

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

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

365

Conditions

Peripheral Vascular Disease

Interventions

Gadopentetate dimeglumine (Magnevist, BAY86-4882)DRUG

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

Gadopentetate dimeglumine (Magnevist, BAY86-4882)DRUG

Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease

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