Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches - Tabular View

Tracking Information

First Received Date ^ICMJE

March 31, 2006

Last Updated Date

July 6, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To evaluate the safety and efficacy of Magnevist® Injection enhanced MRA in comparison to non contrast MRA for the detection of structural abnormalities of the aortic arch, brachiocephalic trunk and subclavian, vertebral and carotid arteries using X-ray

Change History

Complete list of historical versions of study NCT00310609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Diagnostic confidence [ Time Frame: At blinded and/or open label read of the images ]
Visual assessment of stenosis [ Time Frame: At blinded and/or open label read of the images ]
Difference in degree of stenosis [ Time Frame: At blinded and/or open label read of the images ]
Other diagnostic findings [ 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 artifacts [ Time Frame: At blinded and/or open label read of the images ]
Ability to visualize arterial segments [ Time Frame: At blinded and/or open label read of the images ]
Proportion of correctly categorized maximum stenosis per segment [ Time Frame: At blinded and/or open label read of the images ]
Number of evaluable segments [ Time Frame: At blinded and/or open label read of the images ]
Duration if 2D TOF and CE-MRA [ Time Frame: At blinded and/or open label read of the images ]
Patient management [ Time Frame: From baseline to 24 hours follow-up ]
Safety variables [ Time Frame: From baseline to 24 hours follow-up ]

Original Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches

Official Title ^ICMJE

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 Aortic Arch and Cerebral Branches Who Are Undergoing MRA of These Vessels 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 aortic arch and cerebral branches. 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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cardiovascular Abnormalities

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

129

Completion Date

October 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Has known or suspected disease of the aortic arch and cerebral branches
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 previous bilateral intervention (surgery, bypass) of the arteries of interest

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00310609

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

90941, 304630

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP