NCT04995757已完成不适用
Prospective, Randomized, Controlled, Open Label, Single Blinded, All China, Multi-Center, Registration Trial of the Thrombectomy System for the Treatment of Acute Ischemic Stroke.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Successful Recanalization Rate
研究概览
简要总结
As this will be a pre-market registration trial, in which devices will be used in accordance with appropriately labeled indications, pre-study notifications and approval requests will be addressed with CFDA. All trial results will be shared with CFDA.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must demonstrate clinical signs and symptoms that are attributable to the targeted lesion and are consistent with the diagnosis of acute ischemic stroke (AIS), as confirmed by a neuroradiologist (or equivalent expert), using appropriate imaging. Arterial occlusion of ICA, MCA-M1 or MCA-M
- •Female or male subject, who, at the time of consenting, is aged between 18 and 80 years, inclusive.
- •Within 6 hours of stroke symptom onset, subject must have undergone treatment initiation (vascular access through puncture or cut down).
- •Signed Informed Consent Form (ICF) completed by subject or subject's legal representative.
排除标准
- •Functional dependence prior to stroke onset, defined as a pre-stroke modified Rankin Scale (mRS) score of ≥
- •Subject's baseline NIHSS score <2 or >
- •History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history.
- •Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor.
- •Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
- •Subject has a known hemorrhagic diathesis, coagulation factor deficiency; or, is on oral anticoagulant therapy and has an International Normalized Ratio (INR) >
- •Subject's baseline platelet count is <30*10^9/L.
- •Subject's baseline glucose is <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.2 mmol/L).
- •Renal failure, as defined by a serum creatinine >3.0 mg/dL (264 µmol/L) [NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels].
- •Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mmHg) [if the blood pressure can be successfully reduced and maintained at the acceptable level, using medication, the patient can be enrolled].
- •Subject has known allergy or contraindication to one or more of the following: anti-platelet drugs; contrast dye; and/or, local or general anesthesia.
- •Subject has known allergy to nickel, cobalt chromium, tungsten, platinum or other metal that may be a component of a required medical device needed for treatment.
- •Subject is generally unsuitable for endovascular intervention or anesthesia.
- •Subject has had major surgery within the previous 30 days
- •Subject is an active participant in another drug or device treatment trial for any disease state; or, subject is expected to start participation in another drug or device trial while enrolled in this protocol.
- •Subject currently has infective endocarditis or other severe, active bacterial infection.
- •Subject's life expectancy is less than 6 months.
- •Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
- •Imaging Exclusion Criteria:
- •Subject has CT scan or MRI evidence of the following:
- •Significant mass effect with midline shift.
- •Evidence of intracranial tumor, except small meningioma.
- •Evidence of intracranial hemorrhage.
- •Evidence of internal carotid artery flow limiting dissection.
- •Suspected cerebral vasculitis.
- •Suspected aortic dissection.
- •Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) or clinical evidence of bilateral strokes or strokes in multiple territories.
- •The presence of a large completed territorial infarction by non-contrast CT (NCCT), defined as an Alberta Stroke Program Early CT Score (ASPECTS) ≤
- •Other unusual morphology or lesion that might interfere with device use, including but not limited to the following:
- •Carotid dissection
- •Vasculitis
- •Aortic dissection
- •No transfemoral or alternative access, such as:
- •Severe intracranial tortuosity
- •Severe intracranial vasospasm, unresponsive to pharmacotherapy.
- •Other anatomical or clinical conditions contraindicated for access.
- •Anterior circulation strokes involving > 1/3 of the MCA territory, as determined by hypo-density on the baseline non-contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images.
- •Thrombotic occlusion in the posterior circulation arteries (vertebral, basilar, etc.)
- •Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy device.
结局指标
主要结局
Successful Recanalization Rate
时间窗: immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)
Defined as modified treatment in cerebral infarction (mTICI) ≥ 2b
次要结局
- Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment(30±6 hours' post-treatment)
- Time from puncture to mTICI≥2b(immediate post-thrombectomy (t-0))
- The NIHSS score at 30H post-treatment(30± 6 hours' post-treatment)
- AE/SAE within 90D post-treatment(90± 14 days' post-treatment)
- mRS at D90(90± 14 days' post-treatment)
- Death within 90D post-treatment(90± 14 days' post-treatment)
- Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment(90± 14 days' post-treatment)
研究者
研究点 (1)
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