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Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

NCT06374498 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

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.

DRUG

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.

DEVICE

OCT-NIRAF following LUMISIGHT Injection

Subjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram.

Sponsors & Collaborators

Principal Investigators

  • Guillermo J Tearney, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-08
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06374498 on ClinicalTrials.gov