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Completed

NCT Number: NCT05720975

Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke 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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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
  • mRS > 2.
  • 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)

Treatment and study plan

iNstroke

Device

Patients to undergo thromboaspiration with iNstroke.

Primary outcomes

  1. Performance success

    Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.

    Recanalization rate with mTICI ≥2b-3 (modified thrombolysis in cerebral infarction scale).

  2. MAE

    Time frame: 24 hours (-8/+12 hours)

    All serious adverse events.

  3. Mortality

    Time frame: 90 days

    All-cause mortality.

Secondary outcomes

  1. Navigability

    Time frame: 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.

  2. Clinical progress

    Time frame: 90 days

    Good functional clinical progress (modified Rankin scale 0-2).

  3. Proportion of patients with rapid neurological improvement

    Time frame: 24 hours

    Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale)

  4. Reduction of NIHSS scale

    Time frame: 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]).

  5. Procedure duration

    Time frame: 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.

  6. Number of passes with the device until recanalisation.

    Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.

    Number of passes with the device until recanalisation.

  7. Percentage of effective recanalisation in a first pass

    Time frame: 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.

  8. Rate of need to use another reperfusion technique

    Time frame: 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.

  9. Assessment of symptomatic intracerebral haemorrhage

    Time frame: 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).

  10. Neurological deterioration

    Time frame: 24 (-8/+12) hours.

    Classification of neurological deterioration of ≥4 points on the NIHSS scale.

  11. Embolization rate

    Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.

    Embolization rate in a previously non-involved territory on cerebral angiography.

  12. Mortality rate

    Time frame: 3 days (+/-24 hours) or at discharge, whichever occurs first.

    Mortality rate related to the procedure

  13. Procedure complication rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

iVascular S.L.U.

Industry

Registry information

Official study title

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

Acronym: ASPiC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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