A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients

The purpose of this study is to demonstrate the safety and performance of the MIVI Neuroscience, Inc. CE Marked Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke. The study is an observational study collecting Q Aspiration Catheter use that will enroll a maximum of 50 subjects at a maximum of 5 sites in Spain. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit. This study is designed for observational data to be collected and reported.

Inclusion criteria

• Age 18 to 85 years;
• Diagnosis of acute ischemic stroke with mechanical thrombectomy procedure < 8 hours from onset of symptoms/ last known well;
• Large Vessel Occlusion on CT or MRI in the anterior cerebral vasculature up to A1, M1, or M2 or the posterior cerebral vasculature;
• ASPECTS 6 - 10 or volume of diffusion restriction < 50 mL;
• Use of the Q Aspiration Catheter as the first line treatment according to the IFU;
• Signed informed consent by patient or legally authorized representative.

Exclusion criteria

• Occlusions in multiple vascular territories, extracranial occlusion or tandem occlusion;
• Evidence of dissection in the carotid or target artery for treatment;
• Evidence of recent/fresh haemorrhage on presentation;
• Unwilling to agree to a 3-month follow up visit.