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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 : October 31, 2007
Sponsor:
Information provided by:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Gadodiamide
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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.

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
Germany
Amersham Buchler GmbH & Co. KG
Ismaning, Germany
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Michael Karl GE Healthcare
More Information

ClinicalTrials.gov Identifier: NCT00209443     History of Changes
Other Study ID Numbers: SOV302
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by GE Healthcare:
Aorto-iliac Stenosis
Occlusion
Diagnostic Imaging
Omniscan
Magnetic Resonance Angiography
Contrast Media

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases