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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

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.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight; Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight
Experimental: Arm 2	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight; Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Patient management	From baseline to 24 hours follow-up
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
Image evaluability and presence of artifacts	At blinded or/and open label read of images
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
Safety	From baseline to 24 hours follow-up

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Study Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: September 10, 2005
• First Submitted That Met QC Criteria: September 10, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Structural abnormalities of the infrarenal aorta and peripheral arteries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 91208 (Other Grant/Funding Number: Broad Institute); 306781