Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT00335335
Status:
TERMINATED
Last Update Posted:
2019-04-25
First Post:
2006-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Sponsor:
GE Healthcare
Organization:
Study Overview
Official Title:
Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision due to low subject recrcuitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body.
VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.
VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: