check_circleStudy Completed
Peripheral vascular disease
Bayer Identifier:
91208
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
365Trial Dates
March 2003 - August 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoPrimary Outcome
- Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant diseasedate_rangeTime Frame:Image creation after injection - evaluation at blind readenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Diagnostic confidencedate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Visual assessment of stenosisdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Difference in degree of stenosisdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Other diagnostic findingsdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Image qualitydate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Image evaluability and presence of artifactsdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Ability to visualize arterial segmentsdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Number of evaluable segmentsdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Location and matching of stenosisdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- SI measurementsdate_rangeTime Frame:At blinded or/and open label read of imagesenhanced_encryptionNoneSafety Issue:
- Patient managementdate_rangeTime Frame:From baseline to 24 hours follow-upenhanced_encryptionNoneSafety Issue:
- Safetydate_rangeTime Frame:From baseline to 24 hours follow-upenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2