NCT07376447尚未招募不适用
Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke
iVascular S.L.U.11 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2026年5月31日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 11
- 主要终点
- Recanalization Rate
研究概览
简要总结
Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke
详细描述
This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.
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 ≥ 18 years of age.
- •Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
- •Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
- •Baseline NIHSS score ≥6 assessed before the procedure.
- •Pre-morbid [xB13.1]stroke baseline mRS ≤
- •Subjects with an ASPECTS ≥
- •Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.
- •As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).
排除标准
- •Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
- •Severe allergy to contrast media.
- •As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.
- •Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
- •Multiple Intracranial Occlusions
- •Known medical history of thrombocytopenia (Platelets <100,000).
- •Presence of intracerebral hemorrhage.
- •Significant mass effect and/or midline shift.
- •Evidence of intracranial tumor (except small meningioma).
- •Intracranial stenosis proximal to the occlusion.
- •Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included.
- •Known or suspected cerebral vasculitis.
- •Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
- •Current participation in an interventional drug or device study that may confound the results of this study.
研究组 & 干预措施
Thromboaspiration using iNstroke 4F and/or iNstroke 6F aspiration catheter
Other
No comparator will be used in this clinical investigation as it is an exploratory study of a CE-marked medical device to be used within the scope of its intended purpose.
干预措施: Thromboaspiration catheter (Device)
结局指标
主要结局
Recanalization Rate
时间窗: Intra-procedure
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever.
次要结局
未报告次要终点
研究者
研究点 (11)
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