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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention

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

Intervention / Treatment
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* Device: Dual-modal OCT-FLIm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single group patient enrollment and scheduled 6-month follow-up assessment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracoronary imaging<br>Intracoronary imaging during PCI | Device: Dual-modal OCT-FLIm<br>* Intracoronary imaging using dual-modal OCT-FLIm catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence lifetime imaging, High-risk coronary plaque, Optical coherence tomography, Intravascular imaging, Biochemical imaging