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

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: iNstroke

• Registration Number: NCT05720975
• Lead Sponsor: iVascular S.L.U.

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.

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 Timeline

• Study First Submitted: 2022-07-21
• Study Start: 2022-12-26
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Primary Completion: 2025-01-07
• Study Completion: 2025-01-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

1. 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.
2. Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
3. Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
4. 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.
5. Initial NIHSS score before procedure > 6.

Exclusion Criteria

1. Patients under 18 years of age.
2. Patients with an ASPECTS score <6.
3. Baseline NIHSS obtained before procedure of ≤ 6 points.
4. Severe comorbidity and/or shortened life expectancy
5. mRS > 2.
6. Serious allergy to contrast medium.
7. Pregnant women.
8. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
9. Personal history of thrombocytopaenia (<40,000 platelets)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: iNstroke	iNstroke	Study device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
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
Neurological deterioration	24 (-8/+12) hours.	Classification of neurological deterioration of ≥4 points on the NIHSS scale.
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)
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.
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.
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).

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain