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

Primary Purpose

Stenosis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Gadopentetate dimeglumine (Magnevist)

About this trial

This is an interventional diagnostic trial for Stenosis focused on measuring Stenosis of the calf and/or pedal arteries

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic confidence

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

Location and matching of stenosis

Image quality

Image evaluability and presence of artefacts

Ability to visualize arteries

Exact categorization of stenosis

Number of evaluable arteries

Duration of 2D-TOF and MRA

Artery appropriate for bypass

Patient management

Safety

Full Information

NCT ID

NCT00309075

First Posted

March 30, 2006

Last Updated

December 29, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00309075

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 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 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.

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

Stenosis

Keywords

Stenosis of the calf and/or pedal arteries

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gadopentetate dimeglumine (Magnevist)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Image creation after injection - evaluation at blind read

Secondary Outcome Measure Information:

Title

Diagnostic confidence

Time Frame