Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.
The study will enroll 264 subjects overall in two groups (randomized 1:1). The study follow-up will occur at 1, 6 and 12 months post-stent implantation. All patients will undergo angiography assessment (DSA/CTA) at 12 months follow-up. Angiography assessment will be performed at baseline (pre- and post-procedure) and 12 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
272
A sirolimus eluting intracranial stent system with polylactic-co-glycolic acid (PLGA) biodegradable drug carrier and electro-grated polybutyl methacrylate (PBMA) base coating. The stent platform is made of 316L stainless steel.
A 316L stainless steel balloon-expandable intracranial stent system
Beijing Tiantan Hospital
Beijing, China
In stent restenosis rate (> 50% restenosis)
Angiography assessment at 12 months post-procedure
Time frame: 12 months post-procedure
Stroke and death events
Time frame: within 30 days after stenting
Target vessel ischemic stroke event
Time frame: between 30 days and 1 year post-procedure
Acute procedural success rate (stenosis < 30%)
Time frame: 1 year
Target vessel stroke or death events
Time frame: within 30 days after stenting
Non-target vessels ischemic stroke event
Time frame: between 30 days and 1 year post-procedure
Recurrent ischemic stroke in the involved vascular area
Time frame: between 30 days and 1 year post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events
Time frame: between 30 days and 1 year post-procedure
Death event
Time frame: between 30 days and 1 year post-procedure
Transient ischemic attack event
Time frame: within 1 year post-procedure
National Institutes of Health Stroke Scale (NIHSS) evaluation
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Time frame: at 1 and 12 months
modulate RANK score (mRS)evaluation
Time frame: at 1 and 12 months
Montreal Cognitive Assessment (MoCA) evaluation
Time frame: at 1 and 12 months
EQ-5D score evaluation
Time frame: at 12 months