Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries
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.
2 other identifiers
interventional
126
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2003
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 30, 2006
CompletedFirst Posted
Study publicly available on registry
March 31, 2006
CompletedDecember 30, 2014
December 1, 2014
March 30, 2006
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
Image creation after injection - evaluation at blind read
Secondary Outcomes (12)
Diagnostic confidence
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
At blinded and/or open label read of the images
Location and matching of stenosis
At blinded and/or open label read of the images
Image quality
At blinded and/or open label read of the images
Image evaluability and presence of artefacts
At blinded and/or open label read of the images
- +7 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
Eligibility Criteria
You may qualify if:
- Has known or suspected disease of the calf and/or pedal arteries
- Is scheduled for X-ray angiography
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2006
First Posted
March 31, 2006
Study Start
December 1, 2003
Study Completion
November 1, 2004
Last Updated
December 30, 2014
Record last verified: 2014-12