A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00209443|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 25, 2019
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Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.
|Condition or disease||Intervention/treatment||Phase|
|Aorto-iliac Stenosis Arterial Occlusive Diseases||Drug: Gadodiamide Injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Phase 3, Open-Label Study to Assess the Efficacy and Safety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) for Magnetic Resonance Angiography (MRA) of the Aorto-iliac Arteries|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||February 28, 2006|
|Actual Study Completion Date :||February 28, 2006|
Experimental: Gadodiamide Injection
All subjects received a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide Injection) at a dose of 0.1 mmol/kg
Drug: Gadodiamide Injection
Other Name: Omniscan
- 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. [ Time Frame: 27 hours ]
- 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 [ Time Frame: 27 hours ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Study subjects must be adults with confirmed or suspected aorto-iliac stenosis.
- The subject must have been referred for Digital Subtraction Angiography.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209443
|Amersham Buchler GmbH & Co. KG|
|Study Director:||Michael Karl||GE Healthcare|
|Responsible Party:||GE Healthcare|
|Other Study ID Numbers:||
|First Posted:||September 21, 2005 Key Record Dates|
|Last Update Posted:||April 25, 2019|
|Last Verified:||April 2019|
|Studies a U.S. FDA-regulated Device Product:||No|
Magnetic Resonance Angiography
Arterial Occlusive Diseases