The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Device: Ewata balloon guiding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke within 8 hours Patients aged 18-80 years (including critical point) NIHSS score 4-30 (including critical points) Pre-onset mRS score <2 Large vessel lesions were detected by head CT, CTA, MRI, MRA, or DSA The patient or his legal guardian voluntarily signs and dates a written informed 8.consent approved by the ethics committee (IBC). Exclusion Criteria: Head CT exclusion criteria (exclusion if any of the following conditions are met) Cerebral hemorrhage Intracranial tumors, except for small meningiomas Large area of early cerebral infarction (low density shadow >1/3 cerebral hemisphere) Clinical and laboratory exclusion criteria seizure Symptoms of nervous system loss improved rapidly Severe stroke (NIHSS≥31 points) or mild stroke (NIHSS≤3 points) CT examination of the skull was negative, but subarachnoid hemorrhage was not excluded from clinical symptoms A history of intracranial hemorrhage and subarachnoid hemorrhage A history of cranial trauma in the last 3 months A history of cerebral or myocardial infarction in the last 3 months A history of gastrointestinal or urinary tract bleeding in the last 3 weeks A history of major surgery in the last 2 weeks A history of arterial puncture in the last l weeks that was difficult to stop bleeding Patients with severe cardiac, hepatic or renal insufficiency (>250 mol/L) or severe diabetes mellitus Physical examination revealed evidence of active bleeding or trauma, such as a fracture Oral anticoagulants have been taken, and INR>1.7 Blood glucose <2.7 mmol/L or >22.2 mmol/L Systolic blood pressure >185 mmHg, or diastolic blood pressure >110 mmHg Pregnancy There is a tendency of severe bleeding or bleeding disease, platelet count ≤80x109 /L Systemic infection without control or local infection of puncture point Hypersensitivity to contrast media

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balloon<br>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. | Device: Ewata balloon guiding<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Vascular recanalization | TICI≥2b | postoperative | 
| Rate of intraoperative adverse events | including vascular perforation , incision,vasospasm caused by balloon guiding,balloon guide catheter rupture and other instrument-related accidents | intraoperative | 
| The time from the successful puncture to the expected location of ewata | time data | intraoperative | 
| The time from successful puncture to recanalization | time data,TICI≥2b | intraoperative | 
| Rate of symptomatic intracranial hemorrhage within 24 hours | CT/NIHSS | 24 hours | 
| 24-hour mortality | The number of all deaths reported will be recorded and adjudicated | 24-hour | 
| 90-day mortality | The number of all deaths reported will be recorded and adjudicated | 90-day | 
| Good prognosis rate at 90 days | (mRS≤2) | 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 | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIS balloon guiding