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

Primary Purpose

Aorto-iliac Stenosis, Arterial Occlusive Diseases

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Gadodiamide Injection
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aorto-iliac Stenosis focused on measuring Aorto-iliac Stenosis, Occlusion, Diagnostic Imaging, Omniscan, Magnetic Resonance Angiography, Contrast Media

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amersham Buchler GmbH & Co. KG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gadodiamide Injection

Arm Description

All subjects received a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide Injection) at a dose of 0.1 mmol/kg

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
April 24, 2019
Sponsor
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00209443
Brief Title
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 28, 2006 (Actual)
Study Completion Date
February 28, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed Description
GEHC has decided not to provide this detail

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aorto-iliac Stenosis, Arterial Occlusive Diseases
Keywords
Aorto-iliac Stenosis, Occlusion, Diagnostic Imaging, Omniscan, Magnetic Resonance Angiography, Contrast Media

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gadodiamide Injection
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Gadodiamide Injection
Other Intervention Name(s)
Omniscan
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Karl
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Amersham Buchler GmbH & Co. KG
City
Ismaning
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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