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

Not Applicable

Completed

• Conditions: Atherosclerotic Plaque; Atherosclerosis Coronary Artery With Angina Pectoris; Thin-cap fIbroatheroma; Atherosclerosis; Atheroscleroses, Coronary
• Interventions: Device: Dual-modal OCT-FLIm

• Registration Number: NCT04835467
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2022-02-14
• Primary Completion: 2022-08-18
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracoronary imaging	Dual-modal OCT-FLIm	Intracoronary imaging during PCI

Primary Outcome Measures

Name	Time	Method
Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)	day 1	Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes

Secondary Outcome Measures

Name	Time	Method
Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)	day 1	Difference in fluorescence lifetime measurement reflecting superficial calficiation according to pre-specified plaque subtypes
Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)	day 1	Difference in fluorescence lifetime measurement reflecting healed property according to pre-specified plaque subtypes

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of