Optical coherence tomography tissue tissue typing - Clinical validatio
- Conditions
- Atherosclerose10011082
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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
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 < 50ml/min)
Pregnancy or inadequate anticonception
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is a quantification of the performance of<br /><br>OC3T as a tissue type imaging tool. This quantification will entail calculation<br /><br>of sensitivity and specificity of the optical attenuation as measured by OCT<br /><br>for three different categories: lipid-rich/necrotic core plaque, macrophage<br /><br>infiltrated regions, and fibrous/calcified tissues. Matched cross-sections will<br /><br>be scored for tissue type in quadrants in Lipiscan/IVUS and macrophage score<br /><br>from OCT variance analysis. These scores will be correlated with optical<br /><br>attenuation measured by OCT. This endpoint will be assessed on a per vessel<br /><br>basis and in the entire data set overall.</p><br>
- Secondary Outcome Measures
Name Time Method <p>OCT<br /><br>Mean, maximal and minimal lumen diameter (mm);<br /><br>Number of lesions, defined as a % diameter stenosis (%DS) >20%. %DS is<br /><br>calculated as (1-MLD/RD)x100, where MLD is minimal lumen diameter, and RD is<br /><br>reference diameter.<br /><br>Lesion type according to published criteria;<br /><br>Lesion composition derived from OC3T processing;<br /><br>If a cap can be identified, minimum cap thickness.<br /><br>Lipiscan/IVUS<br /><br>Calcium deposits from IVUS;<br /><br>Lipid-core plaques from Lipiscan;<br /><br>Lumen area, vessel area, and plaque burden at 1 mm intervals from IVUS.<br /><br>QCA<br /><br>Mean, maximal and minimal lumen diameter (mm).</p><br>