Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT01506960
Status:
TERMINATED
Last Update Posted:
2013-11-18
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was felt that a sufficient number of subjects were enrolled.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.
Detailed Description:
The aims of this study are to:
1. Test the ability of the new NIRS IVUS system to detect lipid pool
2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
1. Test the ability of the new NIRS IVUS system to detect lipid pool
2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
Study Oversight
Has Oversight DMC:
False
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?: