NCT07089355尚未招募不适用
Open-Label, Single-Arm Study Evaluating Toro 88 Super Bore Aspiration Catheter Safety and Efficacy in Mechanical Thrombectomy for Acute Ischemic Stroke in France
Toro Neurovascular, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Incidence of adverse events that may be associated with the use of the experimental device at 24-36h
研究概览
简要总结
The goal of this pilot study is to evaluate the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in acute ischemic stroke patients.
详细描述
This is a prospective, open-label, single-arm, single-center clinical investigation evaluating the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in mechanical thrombectomy for acute ischemic stroke. The study is being conducted at the Hôpital Fondation Adolphe de Rothschild in France.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 and ≤ 90 years at the time of consent
- •Presenting with an acute ischaemic stroke for which symptoms (or last time seen as normal) are < 24h
- •With occlusion of the ICA / the M1 segment of the MCA / a vertebral artery diameter ≥3.5mm / the basilar artery, defined by eTICI≤1
- •Requiring endovascular treatment (mechanical thrombectomy) with or without intravenous thrombolysis
- •For whom the experimental device is the first-line treatment
- •Without pre-existing disability (mRS ≤3 and 6≤ NIHSS ≤30 before stroke)
- •Informed consent signed :
- •By the patient
- •Or consent by a family member/trusted support person if the patient's condition does not allow them to express their consent in writing (L1111-6)
排除标准
- •Arterial dissection
- •Suspicion of vasculitis
- •Suspected intracranial stenosis near the occlusion site
- •Concomitant intracranial haemorrhage
- •Known coagulation disorder
- •Known coagulopathy
- •Known platelet count <50,000/μL
- •Significant mass effect with midline shift
- •Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis
- •INR ≥ 3.0
- •APTT ≥ 2 times normal
- •Systolic blood pressure > 185 mmHg and/or diastolic blood pressure < 110 mmHg
- •Blood glucose < 50 mg/dL or >400 mg/dL according to the last measurement taken before the procedure
- •Known allergy to contrast media
- •Occluded arteries in more than one large vascular territory (at least two of the left and right internal carotid arteries or the territory of a carotid artery and an artery of the vertebrobasilar system).
- •Pregnant or breast-feeding women (urine or serum pregnancy test negative at inclusion).
- •Adults under legal protection (L1121-8)
- •Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3123-1 and persons admitted to a health or social establishment for purposes other than research (L1121-6).
- •Participation in other interventional clinical research
结局指标
主要结局
Incidence of adverse events that may be associated with the use of the experimental device at 24-36h
时间窗: From start of procedure to 24-36 hours post-procedure
次要结局
- eTICI score ≥ 2b67 after the first pass with the experimental device(Immediately after first device pass (intra-procedural))
- Symptomatic intracranial haemorrhage(22 to 36 hours after reperfusion)
- All adverse events(From procedure to 90 days post-procedure)
- NIHSS score(At discharge and at 90 days post-procedure)
- All serious adverse events(From procedure to 90 days post-procedure)
- All-cause death(From procedure to 90 days post-procedure)
- Modified Rankin Score (mRS) ≤ 2(At 90 days post-procedure)
- eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device(Immediately after final device pass (intra-procedural))
- Lesion site reached according to the operator(Intra-procedural)
- eTICI score ≥ 2c after the first pass with the experimental device(Immediately after first device pass (intra-procedural))
研究者
研究点 (2)
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