Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Good clinical outcome
研究概览
简要总结
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.
详细描述
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.
60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute onset neurological sympto m related to occluded vessel
- •within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis
- •contra-indication or failed to int ravenous rt-PA
- •accessible occlusion at ICA, MC A, VA, BA, PCA
- •5-30 of NIHSS
- •0-2 of mRS before onset
- •obtain documented informed co ntent
排除标准
- •following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain
- •occlude 2 major vessel territory
- •allege for contrast media,
- •abnormal PTT/APTT within 4 h ours intravenous heparin
- •hemorrhagic tendency or 3 or more INR with Warfarin administration
- •30000cc or less of Platelet
- •50mg/dL or less of blood sugar
- •uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
- •90days or less life expancy
- •pregnant or lactating
- •join another trial of medicine or medical device
- •ineligible for trial
研究组 & 干预措施
Trial arm
Mechanical thrombectomy using Versi Retriever
干预措施: Versi Retriever thrombectomy (Device)
结局指标
主要结局
Good clinical outcome
时间窗: 90days after procedure
modified Rankin Score is 0-2
次要结局
- Successful recanalization(at end of procedure)
- Good clinical outcome 2(90days after procedure)
- Symptomatic and asymptomatic intracranial hemorrhage(at 24 hours after procedure)
- sever advers event(90days after procedure)
- Successful recanalization(at 3 passes of device in the procedure)
研究者
Nobuyuki Sakai
Director, Neurosurgery
Kobe City General Hospital