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

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.

Full Title of Study: “First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2023

Detailed Description

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. Thirty two 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.

Interventions

  • Device: Dual-modal OCT-FLIm
    • Intracoronary imaging using dual-modal OCT-FLIm catheter

Arms, Groups and Cohorts

  • Experimental: Intracoronary imaging
    • Intracoronary imaging during PCI

Clinical Trial Outcome Measures

Primary Measures

  • Ability of OCT-FLIm in assessing high-risk plaques
    • Time Frame: day 1
    • Lifetime difference according to plaque types

Secondary Measures

  • Ability of OCT-FLIm in assessing plaque compositions
    • Time Frame: day 1
    • Lifetime difference according to plaque compositions

Participating in This Clinical Trial

Inclusion Criteria

  • Age: greater than 20, less than 75 – 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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korea University Guro Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin Won Kim, Jin Won Kim, MD, PhD – Korea University Guro Hospital
  • Overall Official(s)
    • Sunwon Kim, MD, PhD, Study Director, Korea University
    • Dong Oh Kang, MD, PhD, Study Director, Korea University Guro Hospital
    • Jin Won Kim, MD, PhD, Principal Investigator, Korea University Guro Hospital
    • Hongki Yoo, PhD, Study Director, Korea Advanced Institute of Science and Technology
  • Overall Contact(s)
    • Jin Won Kim, MD, PhD, +82-2-2626-3021, kjwmm@korea.ac.kr

References

Lee MW, Song JW, Kang WJ, Nam HS, Kim TS, Kim S, Oh WY, Kim JW, Yoo H. Comprehensive intravascular imaging of atherosclerotic plaque in vivo using optical coherence tomography and fluorescence lifetime imaging. Sci Rep. 2018 Sep 28;8(1):14561. doi: 10.1038/s41598-018-32951-9.

Kim S, Yoo H, Kim JW. Long Journey of Intravascular Imaging: What and How to Look at the Atheroma in Coronary Artery. JACC Cardiovasc Imaging. 2020 Dec 16. pii: S1936-878X(20)31022-6. doi: 10.1016/j.jcmg.2020.11.015. [Epub ahead of print]

Nam HS, Kang WJ, Lee MW, Song JW, Kim JW, Oh WY, Yoo H. Multispectral analog-mean-delay fluorescence lifetime imaging combined with optical coherence tomography. Biomed Opt Express. 2018 Mar 27;9(4):1930-1947. doi: 10.1364/BOE.9.001930. eCollection 2018 Apr 1.

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