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| ID | Type | Description | Link |
|---|---|---|---|
| 307260 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist) | Drug | Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader | Image creation after injection - evaluation at blind read |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| 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 |
| Ability to visualize arteries | At blinded and/or open label read of the images |
| Exact categorization of stenosis | At blinded and/or open label read of the images |
| Number of evaluable arteries | At blinded and/or open label read of the images |
| Duration of 2D-TOF and MRA | At blinded and/or open label read of the images |
| Artery appropriate for bypass | At blinded and/or open label read of the images |
| Patient management | from baseline to 24 hours follow-up |
| Safety | from baseline to 24 hours follow-up |
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |