Status:
COMPLETED
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
Lead Sponsor:
Korea University Guro Hospital
Conditions:
Atherosclerosis Coronary Artery With Angina Pectoris
Atheroscleroses, Coronary
Eligibility:
All Genders
20-80 years
Phase:
NA
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 dat...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04835467
Start Date
February 14 2022
End Date
October 31 2023
Last Update
December 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University Guro Hospital
Seoul, South Korea, 08308