NCT02994563终止不适用
Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study
Amnis Therapeutics8 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2019年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 8
- 主要终点
- All cause mortality (90 days).
研究概览
简要总结
Prospective, single-arm, open label, Safety and Performance clinical investigation.
详细描述
The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical investigation. Population will be subjects with documented untreated, acute ischemic stroke with large vessel occlusion.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged18-85years.
- •Subject who is contraindicated or failed (when the physician withdraws the tPA per physician discretion) intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice. Failed means that the physician does not continue with IV tPA after thrombolysis; there is still an occlusion with TICI that is </= 1 as the relevant inclusion criteria.
- •Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Amnis Thrombectomy Device.
- •NIHSS score ≥
- •Pre-stroke mRS (modified Rankin Scale) score of 0 to
- •Thrombolysis in cerebral infarction (TICI) ≤1 and causative occlusion of the M1 or M2 portion of the MCAs, anterior cerebral arteries, vertebral arteries, basilar artery ,or posterior cerebral arteries (P1 o rP2), confirmed by CT or MR angiography that is accessible to the Amnis thrombectomy device (i.e. according to IFU; 2-5.5 mm).
- •ASPECTS of ≥6 based on CT or MRI that was performed within 60 min prior to the start of endovascular procedure.
- •Subject or subject's legal guardian where regulations permit, signs the Patient Informed Consent and agrees that subject will attend follow-up visits.
排除标准
- •Rapid neurological improvement prior to or at time of treatment suggesting resolution of signs/symptoms of stroke.
- •Estimated time of symptom onset.
- •Baseline NIHSS score <
- •BaselineNIHSS score ≥30 or state of coma.
- •Baseline pre-stroke mRS score >
- •Baseline Thrombolysis in cerebral infarction (TICI) > 2a.
- •Known serious sensitivity to radiographic contrast agent.
- •Arterial tortuosity, pre-existing stent and/o rother arterial disease that would prevent the device from reaching the target vessel.
- •Evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) <
- •Co-morbid conditions:
- •Elevated blood pressure(systolic>185 mm Hg or diastolic >110 mm Hg)
- •Use of warfarin anticoagulation with INR >3.
- •Platelet count <30,000/mm³.
- •Blood glucose concentration <50 mg/dL (2.7 mmol/L).
- •CT/MRI imaging demonstrate smultilobar infarction (hypodensity >1/3 cerebral hemisphere).
- •CT or MRI evidence of mass effect, signs of hemorrhage, arteriovenous malformation or aneurysm or intra-cranial tumor (except small meningioma).
- •Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.
- •Clinical Symptoms or CT/MRI imaging suggest subarachnoid hemorrhage.
- •Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
- •General - related to the protocol or device:
- •Known sensitivity to nickel, titanium metals or their alloys.
- •Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
- •Current participation in another investigational drug or device study.
- •Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- •Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- •Subject has a life expectancy of <90 days.
- •Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
结局指标
主要结局
All cause mortality (90 days).
时间窗: 3 months post-procedure
Determine the number of participants with treatment-related adverse events.
All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).
时间窗: 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.
It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome.
次要结局
- Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.(First 24 hours after treatment.)
- Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.(Immediate post-procedure angiogram.)
- Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.(First 24 hours after treatment)
研究者
研究点 (8)
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