Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209443
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2005-09-13
Brief Title:
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
A Multicentre Phase 3 Open-Label Study to Assess the Efficacy and Safety of 01 mmolkg Omniscan Gadodiamide Injection for Magnetic Resonance Angiography MRA of the Aorto-iliac Arteries
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 thanequal to 50 or occlusion in aorto-iliac arteries Intra-arterial Digital Subtraction Angiography IADSA will be used as the standard of truth
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 thanequal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None