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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 30, 2006

Last Updated Date

March 17, 2009

Start Date ^†

December 2003

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309075 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Diagnostic confidence [ Time Frame: 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 [ Time Frame: At blinded and/or open label read of the images ]
Location and matching of stenosis [ Time Frame: At blinded and/or open label read of the images ]
Image quality [ Time Frame: At blinded and/or open label read of the images ]
Image evaluability and presence of artefacts [ Time Frame: At blinded and/or open label read of the images ]
Ability to visualize arteries [ Time Frame: At blinded and/or open label read of the images ]
Exact categorization of stenosis [ Time Frame: At blinded and/or open label read of the images ]
Number of evaluable arteries [ Time Frame: At blinded and/or open label read of the images ]
Duration of 2D-TOF and MRA [ Time Frame: At blinded and/or open label read of the images ]
Artery appropriate for bypass [ Time Frame: At blinded and/or open label read of the images ]
Patient management [ Time Frame: from baseline to 24 hours follow-up ]
Safety [ Time Frame: from baseline to 24 hours follow-up ]

Original Secondary Outcome Measures ^†

To evaluate patient management, image quality, and artifacts, of Magnevist® Injection enhanced MRA in comparison to non contrast MRA using X-ray angiography as the standard of reference

Descriptive Information

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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Stenosis

Intervention ^†

Drug: Gadopentetate dimeglumine (Magnevist)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

127

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309075

Responsible Party

Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head

Secondary IDs ^††

307260

Study Sponsor ^†

Bayer

Collaborators ^††

Investigators ^†

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.