NCT06042335尚未招募不适用
A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
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 20 subjects. A maximum of 5 investigational centers in Australia will participate. Enrollment is expected to take about 4 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-
- •Diagnosis of acute ischemic stroke with study enrollment time < 24 hours from onset of symptoms.
- •Disabling stroke defined as a baseline NIHSS >
- •Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M
- •The following imaging criteria must also be met:
- •For subjects 0-6hrs onset:
- •MRI criterion: volume of diffusion restriction as assessed by automated core volume software ≤50 mL OR
- •CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images or, computed tomography perfusion (CPT) core as assessed by automated core volume software ≤50 mL.
- •For subjects 6-24hrs onset:
- •≤20mL ischemic core volume if age >80
- •≤30mL ischemic core volume if age <80 and NIHSS 10-20
- •≤50mL ischemic core volume if age <80 and NIHSS >20
- •Signed informed consent from patient or legal representative
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.
- •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.
- •Renal failure (on dialysis).
- •Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
- •Use of warfarin anticoagulation 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).
- •A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
研究组 & 干预措施
DAISe EZ
Experimental
Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
干预措施: DAISe EZ (Device)
结局指标
主要结局
Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
时间窗: 24 Hours [window: 12-36 hours] post procedure
Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.
Successful revascularization
时间窗: Peri-Procedural
Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.
次要结局
未报告次要终点
研究者
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