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Enrolling By Invitation NCT06374498

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Conditions: Cardiovascular Diseases, Coronary Artery Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

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.

Eligibility Criteria

Arm 1: Inclusion Criteria: * 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 Criteria: * CLINICAL EXCLUSION CRITERIA: * Renal insufficiency (GRF\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06374498). StuddyBuddy aggregates publicly available trial information.