Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter for Neurothrombectomy: A Post-Market Clinical Follow-up Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Successful Revascularization
研究概览
简要总结
A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
详细描述
The PERFECT Study is a prospective, multi-center, single arm, post-market clinical follow-up study.
The objective of this post-market clinical follow-up study is to assess the performance of the EMBOVAC Aspiration Catheter in the treatment of acute ischemic stroke in a real-world clinical setting.
The study will also report on clot characteristics and clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject ≥ 18 years old.
- •Subject experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion of the distal intracranial internal carotid artery, middle cerebral artery or anterior cerebral artery
- •A clinical decision has been made to use the EMBOVAC™ aspiration catheter prior to enrollment in the research
- •EMBOVAC™ Aspiration Catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion
- •Pre-stroke mRS ≤ 1
- •Informed Consent has been provided by the subject or the subject's legally authorized representative.
- •Exclusion Criteria
- •Potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements
- •All patients with severe hypertension on presentation. All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy
- •Known cerebral vasculitis.
- •Known cancer with life expectancy less than 12 months.
- •Stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or 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 vessels.
- •Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).
- •Currently participating in an investigational clinical trial that may confound study endpoints.
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Successful Revascularization
时间窗: Day 0 (post-procedure)
Successful revascularization was defined as achieving a final modified thrombolysis in cerebral infarction (mTICI) score of 2b or greater in target vessel. Revascularization was measured by an independent adjudicating imaging core laboratory and were reported using expanded treatment in cerebral infarction (eTICI) scale. eTICI was a 7-point grading system for determining response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent(%) filling of 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 where higher score indicated more successful revascularization.
次要结局
- Percentage of Participants With Successful Revascularization Without Rescue Therapy(Day 0)
- Percentage of Participants With Modified First Pass Effect(Day 0)
- Percentage of Participants With Complete Revascularization(Day 0)
- Time to Recanalization(Day 0)
- Percentage of Participants With Modified Rankin Scale (mRS) Scores 0 to 2 at Day 90(at Day 90)
- Percentage of Participants With First Pass Effect Without Rescue Therapy(Day 0)
- Percentage of Participants With Device Related Serious Adverse Events (SAEs)(Up to Day 90 post procedure on Day 0)
- Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH)(24 hours post procedure on Day 0)
- Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Total Score at 24 Hours Post-procedure(Baseline (Day 0, before procedure) up to 24 hours post procedure on Day 0)
- Number of Participants With All-Cause Mortality Thorugh 90 Days(90 days post procedure on Day 0)