Clinical trial NCT00185276: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Structural abnormalities of the infrarenal aorta and peripheral arteries
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease
timeFrame: Image creation after injection - evaluation at blind read
Secondary outcomes:
measure: Diagnostic confidence
timeFrame: At blinded or/and open label read of images
measure: Visual assessment of stenosis
timeFrame: At blinded or/and open label read of images
measure: Difference in degree of stenosis
timeFrame: At blinded or/and open label read of images
measure: Other diagnostic findings
timeFrame: At blinded or/and open label read of images
measure: Image quality
timeFrame: At blinded or/and open label read of images
measure: Image evaluability and presence of artifacts
timeFrame: At blinded or/and open label read of images
measure: Ability to visualize arterial segments
timeFrame: At blinded or/and open label read of images
measure: Number of evaluable segments
timeFrame: At blinded or/and open label read of images
measure: Location and matching of stenosis
timeFrame: At blinded or/and open label read of images
measure: SI measurements
timeFrame: At blinded or/and open label read of images
measure: Patient management
timeFrame: From baseline to 24 hours follow-up
measure: Safety
timeFrame: From baseline to 24 hours follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: