The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis
use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis
Beijing Tiantan Hospital
Beijing, China
RECRUITINGTarget vessel stroke or death event
Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.
Time frame: within 30 days post-procedure
device success rate
The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated.
Time frame: assessed during procedure
target vessel ischemia stroke event
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery
Time frame: between 31days and 12months post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
Any cerebral parenchyma hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage confirmed by MRI or CT from 31 days to 12 months post procedure
Time frame: between 31 days and 12 months post-procedure
target vessel death event
Target-vessel related death 31 days to 12 months postoperatively
Time frame: between 31 days and 12 months post-procedure
National Institutes of Health Stroke Scale score
National Institutes of Health Stroke Scale score at 12 months postoperatively(0-42, higher scores mean a worse outcome)
Time frame: at 12 months post-procedure
Modified Rankin Score score
Modified Rankin Score at 12 months postoperatively(0-5, higher scores mean a worse outcome)
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Time frame: at 12 months post-procedure