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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: iNstroke

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 Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients experiencing acute ischaemic stroke of the anterior circulation with occlusion of TICA, M1, extracranial ICA, vertebral artery segment V4 or basilar artery, treated with iNstroke aspiration catheter and complying with the eligibility criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: iNstroke; Study device	Device: iNstroke; Patients to undergo thromboaspiration with iNstroke.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: iVascular S.L.U.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2022
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Ischemia; Thromboaspiration
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: ASPiC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No