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

Study Overview
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Brief Summary
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The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke.

Detailed Description
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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.

Official Title
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An Observational Study of the Q Aspiration Catheter Used During Neurointervention for Acute Large Vessel Ischemic Stroke in Spain.

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: Q Aspiration Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Q Aspiration Catheter<br>mechanical thrombectomy for acute ischemic stroke | Device: Q Aspiration Catheter<br>* The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Revascularization Rate | Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel | intra-procedural | 
| Symptomatic Intracranial Haemorrhage Rate | Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of >/= 4 points | 24 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device | Defined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy) | intra-procedural | 
| Rate of Embolization to a New Neurovascular Territory (ENT) | As measured by independent Angiographic Core Lab | intra-procedural | 
| Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2 | The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased). | 90 days | 
| Mortality Rate | Rate of all cause mortality | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention