A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac Arteries While Using Gadodiamide

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209443
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Aorto-Iliac Stenosis
Arterial Occlusive Diseases
Drug: Gadodiamide Injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 295
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209443

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

No publications provided

ClinicalTrials.gov Identifier: NCT00209443     History of Changes
Other Study ID Numbers: SOV302
Study First Received: September 13, 2005
Last Updated: October 30, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency

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

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Constriction, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014