Clinical trial NCT05720975: Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Ischemia
Thromboaspiration
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Performance success
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: MAE
timeFrame: 24 hours (-8/+12 hours)
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Navigability
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: Clinical progress
timeFrame: 90 days
measure: Proportion of patients with rapid neurological improvement
timeFrame: 24 hours
measure: Reduction of NIHSS scale
timeFrame: 24 or 72 hours
measure: Procedure duration
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: Number of passes with the device until recanalisation.
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: Percentage of effective recanalisation in a first pass
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: Rate of need to use another reperfusion technique
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: Assessment of symptomatic intracerebral haemorrhage
timeFrame: 24 (-8/+12) hours.
measure: Neurological deterioration
timeFrame: 24 (-8/+12) hours.
measure: Embolization rate
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
measure: Mortality rate
timeFrame: 3 days (+/-24 hours) or at discharge, whichever occurs first.
measure: Procedure complication rate
timeFrame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References: