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

Peripheral Vascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185276
• Other study ID #: 91208
• Secondary ID: 306781
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2005
• Last updated: December 29, 2014
• Start date: March 2003
• Est. completion date: August 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight
• Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease		Image creation after injection - evaluation at blind read
Secondary	Diagnostic confidence		At blinded or/and open label read of images
Secondary	Visual assessment of stenosis		At blinded or/and open label read of images
Secondary	Difference in degree of stenosis		At blinded or/and open label read of images
Secondary	Other diagnostic findings		At blinded or/and open label read of images
Secondary	Image quality		At blinded or/and open label read of images
Secondary	Image evaluability and presence of artifacts		At blinded or/and open label read of images
Secondary	Ability to visualize arterial segments		At blinded or/and open label read of images
Secondary	Number of evaluable segments		At blinded or/and open label read of images
Secondary	Location and matching of stenosis		At blinded or/and open label read of images
Secondary	SI measurements		At blinded or/and open label read of images
Secondary	Patient management		From baseline to 24 hours follow-up
Secondary	Safety		From baseline to 24 hours follow-up

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