Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: iNstroke


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion and receiving neurointerventional treatment with the iNstroke aspiration catheter. Informed consent signed by the patient or their representative. Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6 and occlusion of a large vessel (TICA, M1, and tandem with TICA or M1 occlusion, vertebral or basilar). In those patients with more than 8 hours of symptom onset or with stroke on awakening or unknown onset stroke, treatment should be individualised and there should be a penumbra area in CT perfusion. Baseline NIHSS obtained before procedure of ≥6 points. Exclusion Criteria: Patients under 18 years of age. Patients with an ASPECTS score <6. Baseline NIHSS obtained before procedure of ≤ 6 points. Severe comorbidity and/or shortened life expectancy ERm >2. Severe allergy to contrast media. Pregnant women. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection Medical history of plateletopenia (Platelets <100,000)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNstroke<br>Study device | Device: iNstroke<br>* Patients to undergo thromboaspiration with iNstroke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance success | Recanalization rate with mTICI ≥2b-3 (modified thrombolysis in cerebral infarction scale). | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| MAE | All serious adverse events. | 24 hours (-8/+12 hours) | 
| Mortality | All-cause mortality. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigability | Number of procedures in which the InStroke catheter reaches the intracranial occluded segment (M1, basilar artery) through coaxial system with a microcatheter and without the assistance of other additional devices. | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| Clinical progress | Good functional clinical progress (modified Rankin scale 0-2). | 90 days | 
| Proportion of patients with rapid neurological improvement | Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale) | 24 hours | 
| Reduction of NIHSS scale | Proportion of patients with a reduction of ≥8 points on the NIHSS scale (during the first 24 hours post-treatment), or NIHSS 0-1 (at 72 hours [or at the time of discharge, whichever occurs first]). | 24 or 72 hours | 
| Procedure duration | Procedure duration defined as the time from puncture to when grade ≥2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram. | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| Number of passes with the device until recanalisation. | Number of passes with the device until recanalisation. | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| Percentage of effective recanalisation in a first pass | Percentage of effective recanalisation in a first pass, the effect of which will be measured by a recanalisation rate of TICI2c-3 and TICI 2b-3. | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| Rate of need to use another reperfusion technique | Rate of need to use another reperfusion technique due to suction system failure. | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| Assessment of symptomatic intracerebral haemorrhage | Assessment of symptomatic intracerebral haemorrhage by magnetic resonance imaging (MRI)/computed tomography (CT). ICH is defined as the presence of extravascular blood in the brain or within the skull- ICH is considered symptomatic (SICH) if it is associated with clinical deterioration (worsening of the score National Institutes of Health Stroke Scale (NIHSS) of ≥4 points) or if it causes death and is identified as the predominant cause of neurological deterioration, according to the assessment of an independent clinical events committee (CEC). | 24 (-8/+12) hours. | 
| Neurological deterioration | Classification of neurological deterioration of ≥4 points on the NIHSS scale. | 24 (-8/+12) hours. | 
| Embolization rate | Embolization rate in a previously non-involved territory on cerebral angiography. | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 
| Mortality rate | Mortality rate related to the procedure | 3 days (+/-24 hours) or at discharge, whichever occurs first. | 
| Procedure complication rate | Procedure complication rate: arterial perforation, arterial dissection and severe vasospasm in the target vessel | In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Ischemia, Thromboaspiration