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ENROLLING BY INVITATION
NCT06374498
NA

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-07-08

Completion Date

2027-04-30

Last Updated

2025-10-22

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States