NCT06249776已完成不适用
Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial (GRASSROOT)
Gravity Medical Technology, INC18 个研究点 分布在 3 个国家目标入组 55 人开始时间: 2024年2月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 18
- 主要终点
- All-cause mortality
研究概览
简要总结
The study aims to evaluate the safety and efficacy of the Supernova stent retriever device, developed by Gravity Medical Technology, for treating acute ischemic stroke. The device is used to remove blood clots and restore blood flow to the brain .
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
- •Age 18-85 years old (inclusive).
- •Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
- •Intravenous thrombolysis may be given as per national guidelines and patients receiving or not receiving intravenous thrombolysis will both be eligible for inclusion in the study.
- •Admission NIH Stroke Scale score of 8-25
- •No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
- •Catheter angiographic confirmation of large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, or the basilar artery that is accessible to the Supernova device.
- •For strokes in the anterior circulation, the following imaging criteria should also be met:
- •MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
- •CT criterion: ASPECTS 6 to 10 on baseline NCCT
- •Anticipated life expectancy of at least 6 months.
- •A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent.
排除标准
- •Subject already participating in another study of an investigational treatment device or treatment.
- •Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
- •Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
- •For all patients, severe sustained hypertension with SBP >220 and/or DBP >120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP >185 and/or DBP >
- •Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
- •Known hemorrhagic diathesis.
- •Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.
- •Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
- •Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
- •Platelet count of less than 50,000/ µL.
- •History of severe allergy to contrast medium, nickel, or Nitinol.
- •Intracranial hemorrhage.
- •Significant mass effect with midline shift.
- •Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
- •Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery or common carotid artery).
- •Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting).
- •Females who are pregnant or breastfeeding.
- •Known current use of narcotic drugs at the time of treatment.
- •Prior recent stroke in the past 3 months.
- •Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <
- •Known cerebral vasculitis.
- •Rapidly improving neurological status defined as the improvement of greater than 8 points on the NIHSS or improvement to NIHSS of < 6 prior to the procedure.
- •Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories.
- •Ongoing seizure due to stroke.
- •Evidence of active systemic infection.
- •Known cancer with metastases.
- •Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- •Evidence of dissection in the extra or intracranial cerebral arteries.
- •Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation).
- •Aneurysm in the target vessel.
研究组 & 干预措施
Supernova revascularization device
Experimental
Mechanical thrombectomy with Supernova Stent Retriever
干预措施: Supernova revascularization device (Device)
结局指标
主要结局
All-cause mortality
时间窗: All-cause mortality measured at 90 (±14) days
Safety (All-cause mortality)
Successful reperfusion
时间窗: Day 0 (end of procedure)
Rate of successful reperfusion, defined as modified Thrombolysis in Cerebral Ischemia (mTICI) grade of 2b or higher Grade 0: No reperfusion Grade 3: Complete reperfusion
Symptomatic intracranial hemorrhage
时间窗: sICH measured within 24 (18-36) hours of the study procedure
Safety (Rate of symptomatic intracranial hemorrhage (sICH) as measured by the SITS-MOST criteria) The SITS-MOST definition of SICH is a local or remote type II parenchymal haemorrhage within 22 to 36 hours after treatment (or sooner) associated with a ≥ fourpoint deterioration on the NIHSS score from baseline or from the lowest score from baseline to 24 hours, or leading to death.
次要结局
- Successful Reperfusion at First Pass(Assessed at first pass of the intervention during the procedure)
- Percentage of participants with a modified Rankin Scale (mRS) score of ≤2(90 (±14) days post-treatment)
- Asymptomatic Intracranial Hemorrhage(Day 1 (within 24 hours (18-36 hours) of the procedure))
- Neurological Deterioration(Day 1 (within 24 hours (18-36 hours) of the procedure))
研究者
研究点 (18)
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