NCT04991038撤回不适用
Prospective, Multi-center, Randomized Study to Compare the Safety and Efficacy of the DAISe Thrombectomy System and Stent Retrievers for Neurointervention in Acute Ischemic Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Primary Safety Outcome: Symptomatic intracranial hemorrhage
研究概览
简要总结
Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 and older
- •Pre-stroke independent functional status in activities of daily living with modified Rankin Score 0-1
- •Patient presenting with a disabling stroke device as NIHSS ≥6
- •Thrombolytic therapy (IV tPA), if indicated/administered, was initiated within 3 hours of onset/ last known well according to prescribed dosing.Endovascular treatment intended to be initiated (groin puncture) <24 hours from onset of symptoms or last known well time.
- •Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery.
- •The following image criteria should also be met:
- •For Subjects 0-6hrs onset:
- •MRI Criterion: volume of diffusion restriction as assessed by automated core volume software ≤50mL OR
- •CT Criterion: ASPECTS 6-10 on baseline CT or CTA-source images or, CPT as assessed by automated core volume software ≤50mL
- •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 authorized representative.
排除标准
- •CT or MRI evidence of intracranial hemorrhage on presentation.
- •CT or MRI showing mass effect or intracranial tumor (meningioma >2cm in diameter)
- •CT or MRI evidence of carotid dissection or complete cervical carotid occlusion requiring a stent.
- •Previous stroke within the past 3 months.
- •Known arterial condition (proximal vessel stenosis or pre-existing stent) that would prevent the study devices from reaching the target vessel and/or preclude safe recovery of the study devices.
- •Pregnancy.
- •Severe contrast allergy or absolute contraindication to iodinated contrast.
- •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>185mmHg or DBP >110mmHg)
- •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 48hrs; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
- •Platelet count < 50,000
- •Cerebral vasculitis or evidence of active systemic infection (including COVID-19)
- •Suspicion of aortic dissection, septic embolus, or 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.
- •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
Primary Safety Outcome: Symptomatic intracranial hemorrhage
时间窗: 24hrs post procedure
Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
时间窗: 90 days
次要结局
- All-cause mortality at 90 days(90 days)
- mTICI 2b-3 after first attempt with randomized modality(procedure after first attempt with randomized device)
- mTICI 2c-3 at end of the procedure(procedure after all interventions)
- Rates of procedure and/or device related serious adverse events(90 days)
- Rate of embolization to a new vascular territory (ENT) during procedure(procedure)
- mTICI 2c-3 after randomized modality(procedure after use of randomized device)
- mTICI 2b-3 at end of the procedure(procedure after all interventions)
- Procedure Time(procedure)
- mTICI 2b-3 after randomized modality(procedure after use of randomized device)
- mTICI 2c-3 after the first attempt with randomized modality(procedure after first attempt with randomized device)
- Neurologic/Stroke related mortality at 90 days(90 days)
- Rate of all intracranial hemorrhage at 24hrs(24hrs)
- Patient reported outcome assessment by PROMIS Global-10 at 90 days(90 days)
研究者
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