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
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 ]
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|