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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
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief Summary:

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

Detailed Description:
GEHC has decided not to provide this detail
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Drug Information available for: Gadodiamide

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Amersham Buchler GmbH & Co. KG
Ismaning, Germany
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Michael Karl GE Healthcare
More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00209443    
Other Study ID Numbers: SOV302
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GE Healthcare:
Aorto-iliac Stenosis
Occlusion
Diagnostic Imaging
 Omniscan
Magnetic Resonance Angiography
Contrast Media
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases