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

Multicenter, Open-label Study of the Safety (Open-label) and Efficacy (Open-label and Blinded Reader) of a Single Administration of Approximately 0.1 mmol/kg of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients With Known or Suspected Disease of the Calf and/or Pedal Arteries Undergoing MRA of the Calf and Pedal Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the 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 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.

Study Overview

• Status: Completed
• Conditions: Stenosis
• Intervention / Treatment: Drug: Gadopentetate dimeglumine (Magnevist)

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): 126
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: Gadopentetate dimeglumine (Magnevist); Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader	Image creation after injection - evaluation at blind read

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic confidence	At blinded and/or open label read of the images
Location and matching of stenosis	At blinded and/or open label read of the images
Image quality	At blinded and/or open label read of the images
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader	At blinded and/or open label read of the images
Image evaluability and presence of artefacts	At blinded and/or open label read of the images
Ability to visualize arteries	At blinded and/or open label read of the images
Exact categorization of stenosis	At blinded and/or open label read of the images
Number of evaluable arteries	At blinded and/or open label read of the images
Duration of 2D-TOF and MRA	At blinded and/or open label read of the images
Artery appropriate for bypass	At blinded and/or open label read of the images
Patient management	from baseline to 24 hours follow-up
Safety	from baseline to 24 hours follow-up

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (ACTUAL): November 1, 2004

Study Registration Dates

• First Submitted: March 30, 2006
• First Submitted That Met QC Criteria: March 30, 2006
• First Posted (ESTIMATE): March 31, 2006

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: Stenosis of the calf and/or pedal arteries
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 91251; 307260