Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
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|ClinicalTrials.gov Identifier: NCT01506960|
Recruitment Status : Terminated (It was felt that a sufficient number of subjects were enrolled.)
First Posted : January 10, 2012
Results First Posted : October 18, 2013
Last Update Posted : November 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: InfraReDx Lipiscan IVUS||Phase 4|
The aims of this study are to:
- Test the ability of the new NIRS IVUS system to detect lipid pool
- Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
- Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Coronary stenting with OCT, NIRS/IVUS
All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
Device: InfraReDx Lipiscan IVUS
Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.
- Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS) [ Time Frame: Measured one point in time during cardiac catheterization ]Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.
- Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT). [ Time Frame: Measured at the time of cardiac catheterization ]Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506960
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Ik-Kyung Jang, MD, PhD||Massachusetts General Hospital|