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NCT06374498

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Enrolling by Invitation
NAAges 18+InterventionalBasic science
Massachusetts General Hospital
~70 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:OCT-NIRAFLUMISIGHT InjectionOCT-NIRAF following LUMISIGHT Injection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plaque size estimation using OCT-NIRAF
Measured over Data will be analyzed within 1 year after the procedure.
+2 more outcomes measured

Conditions

Cardiovascular Diseases
Coronary Artery Disease

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NCT06374498

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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
Renal insufficiency (GRF \<60 ml/min /1.73m2 )
History of hypersensitivity to pegulicianine
History of allergic reaction to oral or intravenous contrast agents
History of allergic reaction to polyethylene glycol (PEG)
History of any documented allergic or anaphylactic reactions i.e to drugs or food (eggs, shellfish etc.) or chemicals (rubber, latex etc.) or other clinically significant allergies
Patients who have taken an investigational drug within 14 days of enrollment
Patients with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
Severe concurrent illnesses including, but not limited to ongoing or major or severe active infections, symptomatic congestive heart failure, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.

What this trial measures

  • Plaque size estimation using OCT-NIRAFData will be analyzed within 1 year after the procedure.

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

  • Plaque progression estimate using OCT-NIRAFData will be analyzed within 1 year after the procedure.

    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.

  • Feasibility of using LUMISIGHT/Pegulicianine NIRF to detect the inflammation-driven fluorescenceData will be analyzed within 1 year after the procedure.

    The feasibility of using LUMISIGHT/Pegulicianine NIRF to detect the inflammation-driven fluorescence recorded via OCT-NIRAF catheters.