NCT05720975已完成不适用
First Prospective, Single-arm, Single-centre Study to Evaluate the Efficacy and Safety of the Thromboaspiration Catheter System (iNstroke) for Stroke in Patients With Acute Ischemic Stroke
iVascular S.L.U.1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2022年12月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Performance success
研究概览
简要总结
First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.
详细描述
This is a prospective, single-arm, single-centre clinical safety and efficacy research.
The purpose of the study is to evaluate safety and efficacy the device designed by iVascular for thromboaspiration (iNstroke) in patients who have suffered a stroke and who undergo thromboaspiration due to an acute occlusion of neuro vessels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 with acute ischaemic stroke over 18 years of age caused by large vessel occlusion (TICA, extracranial ICA, M1, vertebral artery segment V4 or basilar artery) and receiving neurointerventional treatment with the iNstroke aspiration catheter.
- •Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
- •Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
- •In patients having onset of stroke more than 8 hours previously, wake-up strokes, or unknown time of onset, treatment must be customised and CT perfusion must show penumbra.
- •Initial NIHSS score before procedure > 6.
排除标准
- •Patients under 18 years of age.
- •Patients with an ASPECTS score <
- •Baseline NIHSS obtained before procedure of ≤ 6 points.
- •Severe comorbidity and/or shortened life expectancy
- •Serious allergy to contrast medium.
- •Pregnant women.
- •Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
- •Personal history of thrombocytopaenia (<40,000 platelets)
结局指标
主要结局
Performance success
时间窗: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Recanalization rate with mTICI ≥2b-3 (modified thrombolysis in cerebral infarction scale).
MAE
时间窗: 24 hours (-8/+12 hours)
All serious adverse events.
Mortality
时间窗: 90 days
All-cause mortality.
次要结局
- Reduction of NIHSS scale(24 or 72 hours)
- Procedure complication rate(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Embolization rate(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Mortality rate(3 days (+/-24 hours) or at discharge, whichever occurs first.)
- Neurological deterioration(24 (-8/+12) hours.)
- Clinical progress(90 days)
- Proportion of patients with rapid neurological improvement(24 hours)
- Procedure duration(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Number of passes with the device until recanalisation.(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Navigability(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Percentage of effective recanalisation in a first pass(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Rate of need to use another reperfusion technique(In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.)
- Assessment of symptomatic intracerebral haemorrhage(24 (-8/+12) hours.)
研究者
研究点 (1)
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