TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Passes for Recanalization
研究概览
简要总结
This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.
详细描述
The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA)
- •Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel
- •Subjects that range in age from 18-85
- •Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30
- •Subjects that the operator feels may be treated with endovascular therapy
- •Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better
- •Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)
- •Subjects who have consented in accordance with local Institutional Review Board requirements
排除标准
- •Absence of large vessel occlusion on neuroimaging
- •Evidence of tandem occlusion on neuroimaging
- •Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction
- •Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)
- •Previously documented contrast allergy that is not amenable to medical treatment
- •Women who are pregnant or breastfeeding at time of intervention
- •Evidence of brain hemorrhage on CT and/or MRI at presenting hospital
结局指标
主要结局
Number of Passes for Recanalization
时间窗: Day 0: Conclusion of Thrombectomy Procedure
The total number of passes with the stent retriever need to attain recanalization will be captured.
Distal Emboli
时间窗: Day 0: Conclusion of Thrombectomy Procedure
Incidence of distal emboli (both to affected vessel and new vessel) will be assessed
Time to Recanalization
时间窗: Day 0: Conclusion of Thrombectomy Procedure
The time required to attain recanalization (TICI 2b/3) in affected vessels
Recanalization after Endovascular Intervention
时间窗: Day 0: Conclusion of Thrombectomy Procedure
Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels
次要结局
- Neurologic Outcomes(90 days after treatment)
- Functional Outcomes(90 days after treatment)
- TRAP Technique(Day 0: Conclusion of thrombectomy procedure)
- Adverse Events(Day 1, Day 5-7 and Day 90)
研究者
Ajit Puri
Principal Investigator
University of Massachusetts, Worcester