Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke

This clinical investigation has been designed to evaluate the efficacy and safety of the iNstroke 5F aspiration catheter for its use in the treatment of LVO, with a view to comparing this product with standard therapy or with other similar products in a future pivotal clinical investigation.

Inclusion Criteria:

• Subjects aged ≥ 18 years.
• Subjects able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well.
• Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
• Baseline NIHSS score ≥ 6 assessed before the procedure.
• Pre-stroke mRS score ≤ 2.
• Subjects with an ASPECTS score ≥ 6.
• Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).
• France-specific inclusion criteria: As applicable under French law, subjects affiliated with a health social security scheme or equivalent.

Exclusion Criteria:

• Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
• Severe allergy to contrast media.
• Women of child-bearing potential.
• Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
• Medical history of thrombocytopenia (Platelets <100,000).
• Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery).
• Subjects with occlusions in multiple vessels.
• Subjects with cancer who have a life expectancy of less than 6 months.
• Pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.
• Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the subject may be included.
• Known or suspected cerebral vasculitis.
• Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
• Current participation in an interventional drug or device study that may confound the results of this study.
• Intracranial stenosis proximal to the occlusion.
• France-specific exclusion criteria: As applicable under French law, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of legal age who are the subject of a legal protection measure.