Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Successful Revascularization With NIMBUS Device
研究概览
简要总结
A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
详细描述
The objective of this study is to assess the efficacy of the NIMBUS Device. The study will also report on clot characteristics and clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form.
- •Patient has had one or two passes of another mechanical thrombectomy device without achieving mTICI 2b or better and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel.
- •mRS 0-1 prior to this stroke.
- •NIMBUS is used on the second or third overall pass to attempt revascularization.
排除标准
- •Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
- •Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).
- •All patients with severe hypertension on presentation (SBP > 220 mmHg and/or DBP > 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (SBP >185 mmHg and/ or DBP >110 mmHg).
- •Known cerebral vasculitis.
- •Known cancer with life expectancy less than 12 months.
- •Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
- •Intracranial stenosis that prevents access to the site of occlusion.
- •Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- •Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
- •Evidence of dissection in the extra or intracranial cerebral arteries.
- •Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
结局指标
主要结局
Percentage of Participants With Successful Revascularization With NIMBUS Device
时间窗: Day 1
Successful revascularization was defined as achieving an modified thrombolysis in cerebrovascular infarction (mTICI) score of 2b or greater as determined by an Independent Core Laboratory. The expanded treatment in cerebral infarction (eTICI) score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent (%) filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in \[90-99%\] of downstream territory; 3=Complete and 100% reperfusion.
次要结局
- Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2(Up to Day 90)
- Percentage of Participants With Successful Procedural Revascularization(Day 1)
- Percentage of Participants With Excellent Procedural Revascularization(Day 1)
- Percentage of Participants With Embolization to a New Territory (ENT)(Day 1)
- Percentage of Participants With First Pass Revascularization Using NIMBUS Device(Day 1)
- Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)(Day 1)
- Number of Participants With All-Cause Mortality(Up to Day 90)