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| ID | Type | Description | Link |
|---|---|---|---|
| 306781 |
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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 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.
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 |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease | Image creation after injection - evaluation at blind read |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic confidence | At blinded or/and open label read of images | |
| Visual assessment of stenosis | At blinded or/and open label read of images | |
| Difference in degree of stenosis |
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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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| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight |
|
| At blinded or/and open label read of images |
| Other diagnostic findings | At blinded or/and open label read of images |
| Image quality | At blinded or/and open label read of images |
| Image evaluability and presence of artifacts | At blinded or/and open label read of images |
| Ability to visualize arterial segments | At blinded or/and open label read of images |
| Number of evaluable segments | At blinded or/and open label read of images |
| Location and matching of stenosis | At blinded or/and open label read of images |
| SI measurements | At blinded or/and open label read of images |
| Patient management | From baseline to 24 hours follow-up |
| Safety | From baseline to 24 hours follow-up |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
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