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Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

NCT06374498 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-22

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-08
Primary Completion
2026-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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