Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
Sponsor: Massachusetts General Hospital
Summary
There are 2 arms to this study. Arm 1: Participants undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that: 1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease. 2. NIRAF coronary artery signal level is a predictor of plaque progression on a per participant, per artery, or per lesion basis. Arm 2: Participants undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF following injection of LUMISIGHT. The primary objective is to assess the feasibility of intravascular detection and spatial localization of LUMISIGHT during routine coronary imaging.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-07-08
Completion Date
2028-04-30
Last Updated
2026-08-14
Healthy Volunteers
No
Interventions
OCT-NIRAF
Subjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram. In addition, the subject will also receive two Coronary Computed Tomography Angiography (CCTA) 12 months apart, and images will be analyzed.
LUMISIGHT Injection
Up to 30 subjects will receive a single intravenous dose of LUMISIGHT administered 2-12 hours prior to their standard-of-care coronary procedure and experimental intravascular imaging.
OCT-NIRAF following LUMISIGHT Injection
Subjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram.
Locations (1)
Massachusetts General Hospital
Boston, Massachusetts, United States