To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings.
This clinical trial uses multicenter, single-arm, prospective trial design,people who met the enrollment requirements were performed with Ewata balloon guiding and stent type thrombectomy device.The clinical results were compared with those of other historical guiding catheter products combined with the stent type thrombectomy device to to evaluate the clinical efficacy and safety of Ewata balloon guide catheter in combination with a stent for thrombectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
The balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
technical success rate of ewata
When the balloon guiding catheter arrives at the desired location, the thrombectomy instrument can enter the balloon guiding catheter smoothly, which can be opened successfully when needed to form a local blockage of blood flow. After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy
Time frame: intraoperative
Rate of Vascular recanalization
TICI≥2b
Time frame: postoperative
Rate of intraoperative adverse events
including vascular perforation , incision,vasospasm caused by balloon guiding,balloon guide catheter rupture and other instrument-related accidents
Time frame: intraoperative
The time from the successful puncture to the expected location of ewata
time data
Time frame: intraoperative
The time from successful puncture to recanalization
time data,TICI≥2b
Time frame: intraoperative
Rate of symptomatic intracranial hemorrhage within 24 hours
CT/NIHSS
Time frame: 24 hours
24-hour mortality
The number of all deaths reported will be recorded and adjudicated
Time frame: 24-hour
90-day mortality
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The number of all deaths reported will be recorded and adjudicated
Time frame: 90-day
Good prognosis rate at 90 days
(mRS≤2)
Time frame: 90 days
The thrombus escapes from the target vessel to other vessels to form new embolism
The form of New thrombosis Judged by DSA or MRA
Time frame: intraoperative