Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 11
- 主要终点
- Recanalization Endpoint
研究概览
简要总结
Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.
详细描述
This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation.
In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.
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
- •Subjects aged ≥ 18 years.
- •Subjects with symptom onset up to 24 hours.
- •Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
- •Baseline NIHSS score ≥5 assessed before the procedure.
- •Pre-stroke mRS score ≤
- •Subjects with an ASPECTS score ≥
- •Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).
排除标准
- •Subjects aged <
- •Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.
- •Baseline NIHSS score <5 assessed before the procedure.
- •Pre-stroke mRS score >
- •Subjects with an ASPECTS score <
- •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.
- •Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
- •Medical history of thrombocytopenia (Platelets <100,000).
- •Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery).
- •Subjects with occlusions in multiple vessels (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy.
- •Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.
- •Subjects participating in a clinical trial at the moment of the inclusion.
- •Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.
研究组 & 干预措施
Thromboaspiration using iNstroke 4F aspiration catheter
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 Endpoint
时间窗: Intra-procedure
Recanalization rate with a modified thrombolysis in cerebral infarction scale (mTICI) score ≥2b in ≤3 revascularization passes using iNstroke 4F aspiration catheter, alone or in conjunction with a SR.
次要结局
- Recanalization Endpoint(Intra-procedure)
- Clinical Endpoint(90 day)
- Safety Endpoint(24 (-8/+12) hours)
- Safety Endpoint(Intra-procedure)
- Safety Endpoint(During hospital admission)
- Safety Endpoint(90 days (±14 days) after the procedure.)