NCT05631483终止不适用
A Feasibility Study for the DAISe Thrombectomy Device in Colombia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Rate of Successful Revascularization
研究概览
简要总结
This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.
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 < 8 hours from onset of symptoms.
- •Disabling stroke defined as a baseline NIHSS >
- •Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M
- •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 (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 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.
结局指标
主要结局
Rate of Successful Revascularization
时间窗: Procedure
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Rate of Symptomatic Intracranial Hemorrhage
时间窗: 24 hours post-procedure
次要结局
- All-cause mortality(Through Acute Hospital Discharge)
- Rate of Procedure related Complications(Through 90 day post-procedure)
- Occurrence of all intracranial hemorrhage(24 hours post-procedure)
- Successful Revascularization after first attempt with DAISe(Procedure)
- Embolization to a New Vascular Territory(Procedure)
- Successful Revascularization at end of procedure(Procedure)
研究者
研究点 (1)
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