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

Prior treatment

• 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.

Other illness

• Pre-stroke mRS score \>2.
• Severe allergy to contrast media.
• Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
• Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.
• Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.

Lab values

• Medical history of thrombocytopenia (Platelets \<100,000).

Age

• Subjects aged \< 18.

Other

• Baseline NIHSS score \<5 assessed before the procedure.
• 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.
• 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 participating in a clinical trial at the moment of the inclusion.

• Subjects aged ≥ 18 years.
• Subjects with symptom onset up to 24 hours.
• Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
• Baseline NIHSS score ≥5 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).