ASPiC: Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: iNstroke Study device |
Device: iNstroke
Patients to undergo thromboaspiration with iNstroke.
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Outcome Measures
Primary Outcome Measures
- Performance success [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 [24 hours (-8/+12 hours)]
All serious adverse events.
- Mortality [90 days]
All-cause mortality.
Secondary Outcome Measures
- Navigability [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
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.
- Clinical progress [90 days]
Good functional clinical progress (modified Rankin scale 0-2).
- Proportion of patients with rapid neurological improvement [24 hours]
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale)
- Reduction of NIHSS scale [24 or 72 hours]
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]).
- Procedure duration [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
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.
- Number of passes with the device until recanalisation. [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
Number of passes with the device until recanalisation.
- Percentage of effective recanalisation in a first pass [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
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.
- Rate of need to use another reperfusion technique [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
Rate of need to use another reperfusion technique due to suction system failure.
- Assessment of symptomatic intracerebral haemorrhage [24 (-8/+12) hours.]
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).
- Neurological deterioration [24 (-8/+12) hours.]
Classification of neurological deterioration of ≥4 points on the NIHSS scale.
- Embolization rate [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
Embolization rate in a previously non-involved territory on cerebral angiography.
- Mortality rate [3 days (+/-24 hours) or at discharge, whichever occurs first.]
Mortality rate related to the procedure
- Procedure complication rate [In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.]
Procedure complication rate: arterial perforation, arterial dissection and severe vasospasm in the target vessel
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion and receiving neurointerventional treatment with the iNstroke aspiration catheter.
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Informed consent signed by the patient or their representative.
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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).
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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.
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Baseline NIHSS obtained before procedure of ≥6 points.
Exclusion Criteria:
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Patients under 18 years of age.
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Patients with an ASPECTS score <6.
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Baseline NIHSS obtained before procedure of ≤ 6 points.
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Severe comorbidity and/or shortened life expectancy
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ERm >2.
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Severe allergy to contrast media.
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Pregnant women.
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Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
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Medical history of plateletopenia (Platelets <100,000)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41013 |
Sponsors and Collaborators
- iVascular S.L.U.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASPiC-01