Clinical Trial
Lepu Medical > Clinical > Clinical Trial > Nano+ OCT Report
Nano+ OCT Report
Date:2016-04-18


In the prospective, multicentre, open-label study, patients were enrolled with documented stable angina or silent ischaemia and planned intervention for up to two de novo coronary lesions. The primary OCT endpoint was the percentage of in-stent neointimal volume obstruction at three months. The secondary endpoints included binary restenosis, stent thrombosis and device-oriented composite endpoints at three months.

 

A total of 45 patients with 47 lesions were enrolled from four European sites. Eventually, 43 patients with 45 lesions underwent OCT examination at three months (one case was excluded for poor image quality and one case due to catheter dysfunction).



 

Optical Coherence Tomography (OCT) was performed in 43 patients. OCT analysis of the primary endpoint, including the neointimal thickness and cumulative frequency of the percentage of covered struts are shown.


 



 



 

The QCA data at pre-procedure, post-procedure and at three months in all 47 lesions are shown.

 
 

The clinical endpoints - Device-oriented composite endpoint (DOCE) rate is analyzed.



Polymer-free sirolimus-eluting stents with a nano-sized-pore surface are effective in inhibiting neointimal tissue proliferation and promoting early vascular healing with high strut coverage at three month follow-up.





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