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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date April 25, 2019
Study Start Date  ICMJE September 2004
Actual Primary Completion Date February 28, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Change History Complete list of historical versions of study NCT00209443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Official Title  ICMJE 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
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.

Detailed Description GEHC has decided not to provide this detail
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Aorto-iliac Stenosis
  • Arterial Occlusive Diseases
Intervention  ICMJE Drug: Gadodiamide Injection
Other Name: Omniscan
Study Arms  ICMJE 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
Intervention: Drug: Gadodiamide Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
407
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
295
Actual Study Completion Date  ICMJE February 28, 2006
Actual Primary Completion Date February 28, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209443
Other Study ID Numbers  ICMJE SOV302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Karl GE Healthcare
PRS Account GE Healthcare
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP