NCT04437862已完成不适用
A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 16
- 主要终点
- Symptomatic intracranial haemorrhage rate
研究概览
简要总结
Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli from the neurovasculature in patients experiencing 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 independent functional status in activities of daily living with mRS 0-
- •A disabling stroke defined as NIHSS ≥ 6
- •In USA thrombolytic therapy (IV tPA) received within 3 hours of onset/ last known well, in Europe treatment with IV tPA received within 4.5 hours from onset/ last known well OR ineligibility for thrombolytic therapy
- •Endovascular treatment intended to be initiated < 8 hours from onset of symptoms or last known well time
- •Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, M2, basilar or intracerebral vertebral artery by baseline neuroimaging CTA/MRA and angiographic imaging with a mTICI Score 0-1
- •For strokes in the anterior circulation the following imaging criteria should also be met: MRI criterion of volume of diffusion restriction visually assessed ≤50 mL OR CT criterion of ASPECTS 6 to 10 on baseline CT or CTA-source images or, significantly lowered cerebral blood volume (CBV) ≤50 mL
- •For strokes in the basilar or vertebral artery, the following imaging criterion should also be met: pc-ASPECTS score 8 to 10 on baseline CT, CTA-source images, or MRI
- •Signed informed consent from subject, acceptable person responsible (e.g. LAR) and/or according to County specific regulatory requirements and local ethical committee or review board requirements
排除标准
- •CT or MRI evidence of intracranial hemorrhage on presentation
- •CT or MRI showing mass effect or intracranial tumor (meningioma > 2 cm in diameter).
- •Previous stroke within the past 3 months
- •Rapidly improving neurological status as determined by Investigator/Neurologist
- •Renal failure/insufficiency with >3.0 mg/dL creatinine prior to procedure
- •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
- •For patients who have received a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure
- •Platelet count < 50,000 mm3
- •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
- •Pregnancy
- •Severe contrast allergy or absolute contraindication to iodinated contrast
- •Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure
- •Difficult endovascular access or 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
- •Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
- •Active participation in another study involving an investigational drug or device
- •A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient
- •Unwillingness to complete follow up visits
结局指标
主要结局
Symptomatic intracranial haemorrhage rate
时间窗: 36 hours post procedure
Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4
Successful revascularization rate
时间窗: Procedure end
Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure
次要结局
- Successful revascularization rate on the first attempt with study device(Procedure)
- ENT rate(Procedure)
- Procedure Time(Procedure)
- Mortality(90 days post procedure)
- Successful revascularization rate with study device(Procedure)
- Procedure Complications(Procedure through 90 days)
- Good functional outcome(90 days post procedure)
- ICH(36 hours post procedure)
研究者
研究点 (16)
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