Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Revascularization Status
研究概览
简要总结
To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.
- Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
详细描述
- Clinical outcomes at 90 days
- Mortality at 90 days
- Device-related serious adverse events (DRSAEs)
- Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-79 (has had 18th birthday, but not yet had 80th birthday)
- •NIHSS 8 - 30
- •Anticipated life expectancy of at least 6 months
- •No significant pre-stroke disability (mRS less than or equal to 1)
- •Written informed consent to participate given by patient or legal representative
- •Angiographic confirmation of a persistent large vessel occlusion, in the internal carotid, middle cerebral M1 and/or M2 segments, basilar or vertebral arteries
- •Treatable within 8 hours of symptom onset, defined as the first pass being made with the Trevo device.
排除标准
- •Baseline glucose of < 50 mg/dL (2.78 mmol) or > 400 mg / dL (22.20 mmol)
- •Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- •Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal
- •Baseline platelet count < 30,000
- •History of severe allergy (more than rash) to contrast medium
- •Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled
- •Woman of child bearing potential who is known to be pregnant
- •Patient participating in another clinical study or protocol
- •For anterior circulation strokes: strokes involving greater than 1/3 of the MCA territory, as determined by hypodensity on the baseline non- contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images
- •For posterior circulation strokes within the midbrain and/or pons, extensive hypodensity on the baseline CT, or low CBV on CT Perfusion imaging, or extensive restricted diffusion on DWI images
- •Baseline CT/MR evidence of significant mass effect with midline shift
- •Baseline CT/MR evidence of hemorrhage
- •Baseline CT/MR evidence of intracranial tumor (except small meningioma)
- •Angiographic evidence of vasculitis or arterial dissection
- •High grade stenosis that cannot be treated safely or which prevents access to the thrombus with the Trevo device
- •Angiographic evidence of excessive arterial tortuosity that precludes the Trevo device from reaching the thrombus
结局指标
主要结局
Revascularization Status
时间窗: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (\<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ... Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717\[PubMed\]
次要结局
- Clinical Outcomes at 90 Days(90-day)
- Mortality at 90 Days(90-day)