First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

Korea University Guro Hospital40 enrolled

Overview

Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.

Fluorescence lifetime imaging (FLIm) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. A combined optical coherence tomography (OCT) and FLIm that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. This study sought to investigate whether the dual-modal intravascular OCT-FLIm is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention. Forty patients with multivessel coronary artery disease, who had at least one obstructive lesion (\>70% diameter stenosis) that is considered suitable for PCI, will be included in the study. Culprit and mildly stenotic non-culprit plaques will be imaged using OCT-FLIm catheter. Six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in FLIm signatures according to treatment strategies (medical therapy, interventional therapy etc).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atherosclerosis Coronary Artery With Angina Pectoris Atheroscleroses, Coronary Atherosclerotic Plaque Thin-cap fIbroatheroma Atherosclerosis

Interventions

Dual-modal OCT-FLImDEVICE

Intracoronary imaging using dual-modal OCT-FLIm catheter

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: greater than 20, less than 80 * Patients with significant coronary artery disease (diameter stenosis \>70%) requiring coronary revascularization * Reference vessel diameter: between 2.5 and 4.0 mm * Obtained informed consent from voluntary participants before study enrollment Exclusion Criteria: * Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc) * Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm * Coronary lesion with heavy calcification * Hemodynamic instability during coronary intervention * Contraindication to antithrombotic therapy * Chronic renal insufficiency (Serum creatinine \>2.0mg/dL) * Severe liver dysfunction (AST/ALT \> 5 times of upper normal limit) * Pregnancy or potential pregnancy * Life expectancy less than 1 year * Patient refused to sign the informed consent at enrollment

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)

Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes

Time frame: day 1

Secondary Outcomes

Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)

Difference in fluorescence lifetime measurement reflecting healed property according to pre-specified plaque subtypes

Time frame: day 1

Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)

Difference in fluorescence lifetime measurement reflecting superficial calficiation according to pre-specified plaque subtypes

Time frame: day 1

Data from ClinicalTrials.gov

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