Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835467
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2021-04-05
Brief Title:
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
Sponsor:
Korea University Guro Hospital
Organization:
Korea University Guro Hospital
Study Overview
Official Title:
First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging OCT-FLIM In Patients Undergoing Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None