The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.
This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is angiographic restenosis at 6 months post-procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
paclitaxel coated balloon catheter for intracranial PTA treatment
The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA.
Beijing Tiantan Hospital
Beijing, China
Nanyang City Central Hospital
Nanyang, China
Shanxi Cardiovascular Hospital
Taiyuan, China
Primary efficacy endpoint: Angiographic restenosis of the target lesion
Definition of Restenosis: 1. Post-procedural residual stenosis \< 30% of target lesion occurs \>50% stenosis within the treated segment at 6 months angiographic follow-up. 2. Post-procedural residual stenosis 30-50% of target lesion occurs \>20% absolute luminal loss within the treated segment at 6 months angiographic follow-up.
Time frame: 6 months post-procedure
Primary safety endpoint: Target vessel stroke or death event
Stroke (Hemorrhagic stroke and ischemic stroke) or death related to target vessels within 30 days postoperatively.
Time frame: within 30 days post-procedure
Device success rate
DCB: The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated. Stent: Successful delivery and deployment of the stent and the delivery system of stent could be retreated successfully.
Time frame: during procedure
Target vessel ischemia stroke event
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively
Time frame: between 31 days and 6 months post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively
Time frame: between 31 days and 6 months post-procedure
Target vessel death event
Target-vessel related death 31 days to 6 months postoperatively
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Time frame: between 31 days and 6 months post-procedure
Transient ischemic attack event
transient ischemic attack event transient ischemic attack event
Time frame: at 6 months post-procedure
National Institutes of Health Stroke Scale score
National Institutes of Health Stroke Scale score at 6 months post-procedure(0-42,higher scores mean a worse outcome)
Time frame: at 6 months post-procedure
Modified Rankin Scale score
Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome)
Time frame: at 6 months post-procedure