NCT05139147终止不适用
A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Rate of symptomatic intracranial hemorrhage
研究概览
简要总结
The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-
- •Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
- •Diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms.
- •Disabling stroke defined as a baseline NIHSS >
- •Thrombolytic therapy (IV tPA) received within 4.5 hours of onset/ last known well according to prescribed dosing OR documented ineligibility for thrombolytic therapy.
- •Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, or M2 with mTICI 0-
- •The following baseline imaging criteria should be met: MRI criterion- volume of diffusion restriction visually assessed ≤50 mL OR ASPECTs score 5-10 or T criterion- ASPECTS 6-10 on imaging NE-CT, CTA and/or CTP available
- •Signed informed consent from patient or legal representative or if applicable, documented medical necessity for inclusion in a clinical study in an emergency followed by signed informed consent.
- •Patient is affiliated in the social security system.
排除标准
- •Computed tomography (CT) or Magnetic Resonance Imaging (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; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
- •Severe contrast allergy or absolute contraindication to iodinated contrast.
- •Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
- •Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
- •Use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
- •Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
- •Cerebral vasculitis or evidence of active systemic infection.
- •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.
- •Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
- •Evidence of dissection in the carotid or target artery for treatment.
- •Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
- •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 cannot undergo an MRI of the head due to MRI contraindication.
- •Patient is unable or unwilling complete follow up visits.
- •If before the stroke, the patient is under a legal protective measure, they will not be able to participate in the study.
结局指标
主要结局
Rate of symptomatic intracranial hemorrhage
时间窗: 12-36 hours
Symptomatic intracranial haemorrhage at 24 (+/-12) hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4
Rate of first pass revascularization success
时间窗: procedure
First pass successful revascularization defined as mTICI (modified Treatment in Cerebral Ischemia) 2b-3 flow in the target vessel post-treatment with the DAISe Thrombectomy System used with aspiration.
次要结局
- Infarct volume(12-36 hours)
- Rate of procedural final successful revascularization(Procedure)
- Rate of successful device use(Procedure)
- Mortality Rate(3 months)
- Rate of successful revascularization with the DAISe Device(Procedure)
- Rate of ENT(Procedure)
- Intracranial hemorrhage(12-36 hours)
- Procedure time(Procedure)
- Complications(Procedure)
- Good functional outcome(3 months)
- Rate of successful revascularization at procedure end(Procedure)
- Emboli(12-36 hours)
研究者
研究点 (10)
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