A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.
This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter (Vmoky) produced by Yinyi (Liaoning) Biotech Co., Ltd. for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Use Vmoky Drug Eluting Balloon to treat patients with symptomatic intracranial atherosclerosis stenosis
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Restenosis
Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss.
Time frame: 6 months (+60 days)
Angiographic success rate
TICI 3 blood flow, residual stenosis no more than 50% after 5 minutes and no flow-limited dissection
Time frame: immediately after procedure
The success rate of device
device successfully cross the lesion and inflate, post-procedural residual stenosis no more than 50%, no use of bail-out stent
Time frame: immediately after procedure
The success rate of procedure
Base on the device success, there is no stroke or death in-hospital
Time frame: In-hospital (Maximum 7 days after procedure)
Target lesion stenosis
Calculate the stenosis degree with Quantitative Coronary Angiography (QCA) method
Time frame: 6 months (+60 days) and 12 months (±60 days)
Restenosis
Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss.
Time frame: 12 months (±60 days)
Stroke events
Number of participants that occur these events
Time frame: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
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Ischemic stroke and transient ischemic attack (TIA) in the area of the responsible blood vessels
Number of participants that occur these events
Time frame: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
Ischemic stroke and transient ischemic attack (TIA) out of the area of the responsible blood vessels
Number of participants that occur these events
Time frame: 30 days (±7 days), 6 months (±60 days), 12 months (±60 days)
Non-stroke bleeding
Number of participants that occur this event
Time frame: 12 months (±60 days)
Mortality
Number of participants that occur this event
Time frame: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
Serious adverse events and adverse events
Number of participants that occur these events
Time frame: 12 months (±60 days)