Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

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.

NCT Number	NCT06374498
Lead Sponsor	Massachusetts General Hospital
Conditions	Cardiovascular Diseases, Coronary Artery Disease
Enrollment	70 participants
Start Date	2024-07-08
Primary Completion	2027-04-30 (estimated)
Study Completion	2028-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-14