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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00209443 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac Arteries While Using Gadodiamide
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Scientific title:
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Date of first enrolment:
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September 2004 |
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Target sample size:
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295 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00209443 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Germany
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Contacts
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Name:
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Michael Karl |
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Address:
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Telephone:
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Email:
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Affiliation:
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GE Healthcare |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Study subjects must be adults with confirmed or suspected aorto-iliac stenosis.
- The subject must have been referred for Digital Subtraction Angiography.
Exclusion Criteria:
- The subject has a known hypersensitivity to either conventional X-ray or gadolinium
based MR contrast media including, but not restricted to, the investigational
product.
- The subject is lactating.
- The subject is pregnant as defined by a serum or urine beta-HCG pregnancy test
obtained within 24 hours before administration of the investigational product.
- The subject received or is scheduled to receive MRI contrast medium within 24 hours
prior to or less than 24 hours after administration of the investigational product.
- The subject received or is scheduled to receive X-ray contrast medium within 24 hours
prior to or less than 24 hours after administration of the investigational product.
- The subject received an investigational product other than OMNISCAN (gadodiamide)
within 30 days prior to OMNISCAN administration or will receive an investigational
product within the follow-up period proposed for this study.
- The subject presents any clinically active, serious, life-threatening disease with a
life expectancy of less than 6 months.
- The subject has a serum creatinine value of >= 3.5 mg/dL (309.4 µmol/L).
- The subject has previously been included in this study.
- The subject has a contra-indication for MRI according to accepted clinical
guidelines.
- The subject has metal implants and/or stents in the aorto-iliac region and/or hip
replacement.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aorto-Iliac Stenosis
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Arterial Occlusive Diseases
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Intervention(s)
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Drug: Gadodiamide Injection
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Primary Outcome(s)
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Differences in subject level and vessel level sensitivity and specificity between CE-MRA and TOF-MRA in detecting stenosis,(>50% occlusion) in aorto-iliac arteries. IA-DSA is the truth standard.
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Secondary Outcome(s)
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Differences in sensitivity, specificity, accuracy, PPV and NPV at subject and/or vessel level between CE-MRA and TOF-MRA in detecting stenosis (50% occlusion) in aorta-iliac arteries; Revascularisation strategies based on CE-MRA, TOF-MRA and IA DSA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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