Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)

Exclusion Criteria14

• Subjects aged < 18.
• Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.
• Baseline NIHSS score <5 assessed before the procedure.
• Pre-stroke mRS score >2.
• Subjects with an ASPECTS score <6.
• 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.
• 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 (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy.
• Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.
• Subjects participating in a clinical trial at the moment of the inclusion.
• Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.