A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Number of participants with successful revascularization
研究概览
简要总结
This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.
详细描述
The study is a prospective, multi-center, single arm study that will enroll a maximum of 90 subjects, plus up to 50 roll-in subjects. A maximum of 10 sites in Europe will be involved in this study. The primary performance endpoint is successful revascularization defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure as detected by CT/MRI with an NIHSS change of >/=4. Subject will be followed through hospital discharge with a visit at Day 1 post procedure, Day 7 or prior to discharge/transfer, 30 days and 3 months.
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
- •Age 18 to 85 years.
- •Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
- •Disabling stroke defined as a baseline NIHSS >
- •Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-
- •If thrombolytic therapy (tPA) is administered, it must be administered per the prescribing information.
- •Confirmed symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs), or M2-MCA.
- •The following baseline imaging criteria should be met: MRI criterion: ASPECTS Score > 4 OR CT criterion: ASPECTS > 6
- •Signed informed consent from patient or legally authorized representative.
排除标准
- •CT or MRI evidence of recent/ fresh hemorrhage on presentation.
- •Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- •Rapidly improving neurological deficits based on the investigator's clinical judgement.
- •Pregnancy
- •Severe contrast allergy or absolute contraindication to iodinated contrast.
- •No femoral pulses or very difficult endovascular access that will result in an inability to deliver endovascular therapy.
- •Evidence of dissection in the carotid or middle cerebral arteries.
- •Severe unilateral or bilateral carotid artery stenosis requiring treatment at the time of the procedure as determined during diagnostic angiography.
- •Renal failure (serum creatinine level ≥ 4 mg/dL or on dialysis).
- •Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg).
- •Cerebral vasculitis.
- •Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
- •Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- •Seizure due to stroke.
- •Platelet count < 50,000/mm
- •A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- •Patient is unable or unwilling complete follow up visits.
结局指标
主要结局
Number of participants with successful revascularization
时间窗: intra-procedural
Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.
Rate of symptomatic intracranial haemorrhage
时间窗: 12-36 hours post procedure
24 hours post-procedure as detected by CT/MRI with an NIHSS change of \>4
次要结局
- Rate of embolization to a new vascular territory (ENT)(intra-procedural)
- Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow(intra-procedural)
- Rate of procedure-related complications(post procedure through discharge)
- Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System(intra-procedural)
- Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System(intra-procedural)
- Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure(intra-procedural)
- Good functional outcome for participants measured by Modified Rankin Scale score of 0-2.(30 days and 3 months post procedure)
- Quality of life for participants: PROMIS Scale(3 months post procedure)
- Rate of all cause mortality(30 days and 3 months post procedure)