Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Device-related Serious Adverse Events
研究概览
简要总结
Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.
详细描述
This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices)
- •Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments
- •Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture
排除标准
- •Significant disease of the ipsilateral common carotid artery on routine CTA
- •Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS
- •Any active or recent hemorrhage within the past 30 days
- •Embolectomy contraindications
- •a. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5
- •IV tPA has been or is being administered
- •Last known well > 24 hours ago
研究组 & 干预措施
NOVIS Transcarotid Neuroprotection System (NPS)
Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS.
干预措施: NOVIS Transcarotid Neuroprotection System (NPS) (Device)
结局指标
主要结局
Number of Device-related Serious Adverse Events
时间窗: 90 Days
The primary outcome measure assesses the number of vascular complications which include which include dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. The endpoint is measured at 90 days post-procedure.
Number of Other Serious Adverse Events
时间窗: 90 Days
The primary outcome measure assesses the number of permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices. The endpoint is measured at 90 days post-procedure.
Number of Subjects With Functional Independence
时间窗: 90 Days
Functional independence will be evaluated by assessing the modified Rankin scale (mRS). The mRS comprises six levels from 0 to 5 of increasing severe disability with an additional level 6 indicating death. A lower score indicates a better outcome and a higher score indicates a worse outcome. A mRS score reported between 0 to 2 will be considered functionally independent and 3 to 6 to not be functionally independent or dead at point of measurement. The endpoint is measured at 90 days post-procedure.
次要结局
- Carotid Access Time(Hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization, neck incision to femoral venous sheath access which, and neck incision to initiation of reverse flow.)
- Time to Final Revascularization(Hospital arrival to OR, LKW to final revascularization, admission to final revascularization, OR to final revascularization, cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow.)
- Number of Device-Related Complications(90 Days)
- Neurologic Assessment(90 Days)
- Technical Sucess Rate(Start to end of index procedure)
- Revascularization Sucess Rate(Start to end of index procedure)