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

N/ACompletedNCT05720975

iVascular S.L.U.113 enrolled

Overview

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.

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

113

Conditions

Acute Ischemic Stroke

Interventions

iNstrokeDEVICE

Patients to undergo thromboaspiration with iNstroke.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hospital Universitario Virgen del Rocío

Seville, Spain

Outcomes

Primary Outcomes

Performance success

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

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

MAE

All serious adverse events.

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

Mortality

All-cause mortality.

Time frame: 90 days

Secondary Outcomes

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.

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

Clinical progress

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

Time frame: 90 days

Proportion of patients with rapid neurological improvement

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

Time frame: 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 \[or at the time of discharge, whichever occurs first\]).

Time frame: 24 or 72 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.