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

Korea University

Status: Completed

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

Treatments: Device: Dual-modal OCT-FLIm

Study type: Interventional

Funder types: Other

Identifiers

NCT04835467

SRFC-IT1501-05

Details and patient eligibility

About

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 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).

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intracoronary imaging

Experimental group

Description:

Intracoronary imaging during PCI

Treatment:

Device: Dual-modal OCT-FLIm