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NeoVas FIM Report
Date:2016-06-03

6-month Angiographic, IVUS, OCT, 1-Year MSCT and Clinical Results of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients with de Novo Coronary Artery Lesion (NeoVas TM): the First-in-Man Study was first reported in EuroPCR 2016 conference.

The LEPU MEDICAL NeoVas TM sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold, bioresorbable poly lactic acid (PLLA) coating carrier and contains the antiproliferative drug – Sirolimus. 
 

 
The NeoVas TM First-in-Man Study is a prospective, two-center study which verified the feasibility, preliminary safety and efficacy of NeoVas TM initially in patients with de novo coronary lesion.

Approximately 30 subjects were enrolled and received NeoVas TM treatment. Subjects will have clinical follow-up at 30, 180 and 270 days and at 1, 2, 3 and 5 years. The primary endpoint is target lesion failure (TLF) at 30 days follow-up. TLF is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization (iTLR).
 


The Angiographic Results can be divided into
Intention-to-Treat Population and Per Protocal Set. Among those factors, minimum lumen diameter (MLD) slightly decreased from post-procedure to 6-month follow-up, which was also reflected in cumulative frequency (data not shown). A slight acute recoil at 6-month was 0.15mm. In addition, there was only one in-scaffold binary restenosis case, and late lumen loss (LLL) in scaffold was 0.26.
 



The IVUS results noted that mean vessel area remained unchanged in 6-month follow-up, and the mean lumen area slightly reduced from 8.69 to 8.22 mm2. Both scaffold volume obstruction and late percent recoil were quite low.



Similar results were found in 6-month OCT examinations and 1-year MSCT results. Proportion of covered struts in 6-month reached a very high point at 95.7%, with few incomplete strut apposition (0.58%). And area stenosis was 22.6%, which was acceptable.


 



As for 1-year clinical outcomes, no death was occurred and one case suffered the myocardial infarction (MI) while it’s not related to target vessel. One patient suffered target lesion revascularization (TLR) within 6-month. In total the 1-year TLF is 3.2%.

 




The present FIM Study of NeoVas TM Demonstrated the feasibility, preliminary, safety and efficacy of the novel bioresorbable scaffold NeoVas TM in patients with single de novo coronary lesions. And in the near future long-term imaging follow-up results will provide with more valuable information.








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