check_circleStudy Completed
Stenosis
Bayer Identifier:
91251
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Magnevist® Injection enhanced MRA compared to non contrast MRA for the detection of stenosis in the calf and/or pedal 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 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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
126Trial Dates
December 2003 - November 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoPrimary Outcome
- Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded readerdate_rangeTime Frame:Image creation after injection - evaluation at blind readenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Diagnostic confidencedate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label readerdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Location and matching of stenosisdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Image qualitydate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Image evaluability and presence of artefactsdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Ability to visualize arteriesdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Exact categorization of stenosisdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Number of evaluable arteriesdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Duration of 2D-TOF and MRAdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Artery appropriate for bypassdate_rangeTime Frame:At blinded and/or open label read of the 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
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1