Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

NCT06374498 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 2023P003247
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.
2. 2.NIRAF coronary artery signal level is a predictor of plaque progression on a per participant, per artery, or per lesion basis.

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Keywords

Optical Coherence Tomography; NIRAF; Cardiovascular; CAD

Outcome Measures

Primary Outcomes (2)

• Plaque size estimation using OCT-NIRAF

  Optically derived signatures (OCT-NIRAF) will be compared to plaque volume measured by CCTA at baseline.

  Data will be analyzed within 1 year after the procedure.

• Plaque progression estimate using OCT-NIRAF

  Changes in plaque volume will be measured by CCTA at baseline and after 1 year. Optically derived signatures (OCT-NIRAF) obtained at baseline will be compared to changes in plaque volume.

  Data will be analyzed within 1 year after the procedure.

Study Arms (1)

Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography

EXPERIMENTAL

Participants referred to the Cardiology Division of the Massachusetts General Hospital, undergoing coronary angiography for stable or acute coronary disease and eligible for percutaneous coronary intervention (PCI) will be eligible for the study.

Device: OCT-NIRAF

Interventions

OCT-NIRAF DEVICE

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.

Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography in the MGH cardiac catheterization laboratory
• Participant is eligible for PCI
• Participants must be over the age of 18
• Participant must be able to give informed consent
• Women with childbearing potential must have a negative pregnancy test within seven days prior to the procedure

You may not qualify if:

• Renal insufficiency (GRF\<45 ml/min/1.73m2)
• Pregnancy
• Acute myocardial infarction: Participants with ST elevation MI will be excluded for at least 72 hours post event. Participants with non-ST elevation MI will be excluded if they have evidence of ongoing ischemia defined as chest pain or new ECG changes in the previous 12 hours and/or rising cardiac biomarker enzymes (e.g., troponin or CKMB)
• Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema,
• Emergent procedures
• Ejection fraction \<= 35%
• Clinically significant bleeding within the past 14 days
• Any active, serious, life-threatening disease with a life expectancy of less than 12 months
• Inability to be evaluated at follow-up
• Currently enrolled in another study utilizing OCT imaging, or in an investigational trial that involves a non-approved cardiac drug or device
• Participants under the protection of justice, guardianship, or curatorship
• Participant deemed not indicated for intravascular imaging or PCI
• Inability to perform intravascular imaging of a target artery
• Left main disease \>= 50% stenosis in participants that do not have a functioning LAD bypass graft
• Clinical instability that develops after IVUS imaging but prior to OCT-NIRAF imaging

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Guillermo J Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 18, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)