Atherosclerose
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient eligible for percutaneous coronary intervention (PCI) of a native coronary artery Study vessel must be accessible to the OCT and Lipiscan/IVUS catheters Study vessel has at least 20 mm of native artery wall with analyzable OCT image quality Informed consent
Exclusion criteria
Exclusion criteria: Unable to provide informed consent Hemodynamic instability Cardiogenic shock TIMI 0 flow at target lesion site Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse Bypass graft as target vessel Ejection fraction less than 30% Contra-indication to emergency coronary artery bypass surgery No access to cardiac surgery Contra-indication to treatment with aspirin, ticlopidine, clopidogrel, prasugrel or heparin Renal insufficiency (creatinine clearing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is a quantification of the performance of OC3T as a tissue type imaging tool. This quantification will entail calculation of sensitivity and specificity of the optical attenuation as measured by OCT for three different categories: lipid-rich/necrotic core plaque, macrophage infiltrated regions, and fibrous/calcified tissues. Matched cross-sections will be scored for tissue type in quadrants in Lipiscan/IVUS and macrophage score from OCT variance analysis. These scores will be correlated with optical attenuation measured by OCT. This endpoint will be assessed on a per vessel basis and in the entire data set overall. | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT Mean, maximal and minimal lumen diameter (mm); Number of lesions, defined as a % diameter stenosis (%DS) >20%. %DS is calculated as (1-MLD/RD)x100, where MLD is minimal lumen diameter, and RD is reference diameter. Lesion type according to published criteria; Lesion composition derived from OC3T processing; If a cap can be identified, minimum cap thickness. Lipiscan/IVUS Calcium deposits from IVUS; Lipid-core plaques from Lipiscan; Lumen area, vessel area, and plaque burden at 1 mm intervals from IVUS. QCA Mean, maximal and minimal lumen diameter (mm). | — |
Countries
Netherlands
Outcome results
None listed