Viewing Study NCT00335335



Ignite Creation Date: 2024-05-05 @ 4:54 PM
Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00335335
Status: TERMINATED
Last Update Posted: 2019-04-25
First Post: 2006-06-07

Brief Title: Safety and Effectiveness of Visipaque 320mg-Iml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Sponsor: GE Healthcare
Organization: GE Healthcare

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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None