Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06374498
Status
Enrolling By Invitation

Conditions

  • Cardiovascular Diseases
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • LUMISIGHT Injection — DRUG
    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.
  • OCT-NIRAF following LUMISIGHT Injection — DEVICE
    Subjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram.

Study Details

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.

Key Dates

First listed
Apr 18, 2024
Start date
Jul 8, 2024
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography
    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.
  • Experimental: LUMISIGHT Injection
    Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRF following injection of LUMISIGHT . The primary objective of Arm 2 is to assess the feasibility of intravascular detection and spatial localization of LUMISIGHT - derived near-infrared fluorescence during routine coronary imaging.

Primary Outcome Measure

Plaque size estimation using OCT-NIRAF [ Time Frame: Data will be analyzed within 1 year after the procedure. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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