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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

Primary Purpose

Peripheral Vascular Disease

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

About this trial

This is an interventional diagnostic trial for Peripheral Vascular Disease focused on measuring Structural abnormalities of the infrarenal aorta and peripheral arteries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic confidence

Visual assessment of stenosis

Difference in degree of stenosis

Other diagnostic findings

Image quality

Image evaluability and presence of artifacts

Ability to visualize arterial segments

Number of evaluable segments

Location and matching of stenosis

SI measurements

Patient management

Safety

Full Information

NCT ID

NCT00185276

First Posted

September 10, 2005

Last Updated

December 29, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00185276

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease

Keywords

Structural abnormalities of the infrarenal aorta and peripheral arteries

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

365 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Diagnostic confidence

Time Frame