Trials / Completed
CompletedNCT04835467
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Korea University Guro Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Atherosclerosis Coronary Artery With Angina Pectoris
- Atheroscleroses, Coronary
- Atherosclerotic Plaque
- Thin-cap fIbroatheroma
- Atherosclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dual-modal OCT-FLIm | Intracoronary imaging using dual-modal OCT-FLIm catheter |
Timeline
- Start date
- 2022-02-14
- Primary completion
- 2022-08-18
- Completion
- 2023-10-31
- First posted
- 2021-04-08
- Last updated
- 2023-12-04
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04835467. Inclusion in this directory is not an endorsement.