NCT05972252招募中不适用
A Feasibility Study to Evaluate the Safety and Efficacy of the Cerebrovascular Interventional Procedural Control System in Treatment of Acute Ischemic Stroke
Hangzhou Dinova Neuroscience Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Good Neurological Outcome
研究概览
简要总结
The objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the Cerebrovascular Interventional Procedural Control System.
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
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute ischemic stroke.
- •Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or MRA.
- •Subject could be treated intraarterially within 8 hours after symptom onset.
- •Prestroke Modified Rankin Score ≤
- •National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤
- •Patients or their legally authorised representatives provided signed, informed consent.
排除标准
- •NCCT ASPECT score <6，or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area.
- •CT/MR Showed midline shift or cerebral hernia, and ventricle occupying effect. Intracranial hemorrhage. CTA/MRA shows carotid artery dissection, severe stenosis, or complete occlusion, which requiring carotid stent implantation during thrombectomy; Bilateral acute stroke or multiple intracranial large vessel occlusion.
- •Females who are pregnant or lactating.
- •Severe allergy to contrast agents, nickel-titanium metal or its alloys.
- •Drug-resistant hypertension (defined as sustained systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg).
- •Hemorrhagic tendency (including but not limited to platelet <100*109/L, heparin treatment within 48 hours with APTT ≥35s, taking warfarin with an INR > 1.7).
- •Surgery or biopsy of parenchymal organs within the last 1 month
- •Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month
- •Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine >220umol/L or 2.5mg/dl)
- •Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor.
- •Life expectancy of less than 1 year.
- •Enrollment in another clinical trial evaluating other devices or drugs during the same period.
- •Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
结局指标
主要结局
Good Neurological Outcome
时间窗: 90±7 Days post-treatment
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms.
Technical Success
时间窗: Immediately post-treatment
Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.
次要结局
- Radiation Exposure(Immediately post-treatment)
- Symptomatic Intracranial Hemorrhage(36 hours post-treatment)
- Successful Recanalization Rate(Immediately post-treatment)
- All-cause Mortality at 90 days(Through 90 days)
- Successful Revascularization(Immediately post-treatment)
- Time from Groin Puncture to Reperfusion(Immediately post-treatment)
- Device-related Serious Adverse Events (SAEs)(Through 90 days)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Cook Venous Valve System for Treatment of Chronic Venous InsufficiencyVenous Insufficiency of LegNCT05883943MED Institute Inc.4
暂停
1 期
The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral InfarctionCerebral InfarctionNCT03186456Sclnow Biotechnology Co., Ltd.40
已完成
不适用
NitiNotes' EndoZip System for the Treatment of ObesityObesityNCT03472196Nitinotes Surgical Ltd.14
已完成
不适用
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence DeviceUrinary Bladder, OveractiveNCT04001426FemPulse Corporation2
已完成
2 期
Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With SchizophreniaSchizophreniaNCT01323205Janssen Research & Development, LLC100