The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- technical success rate of ewata
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
- •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
研究组 & 干预措施
balloon
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.
干预措施: Ewata balloon guiding (Device)
结局指标
主要结局
technical success rate of ewata
时间窗: intraoperative
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
次要结局
- Rate of symptomatic intracranial hemorrhage within 24 hours(24 hours)
- The time from the successful puncture to the expected location of ewata(intraoperative)
- Rate of Vascular recanalization(postoperative)
- Good prognosis rate at 90 days(90 days)
- 24-hour mortality(24-hour)
- Rate of intraoperative adverse events(intraoperative)
- The time from successful puncture to recanalization(intraoperative)
- 90-day mortality(90-day)
- The thrombus escapes from the target vessel to other vessels to form new embolism(intraoperative)
研究者
Zhongrong Miao
Chief physician
Beijing Tiantan Hospital