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

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Q Aspiration Catheter	Q Aspiration Catheter	mechanical thrombectomy for acute ischemic stroke

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (4): Hospital Virgen de la Arrixaca
🇪🇸
Murcia, Spain
Centro Hospitalario Universitario Donostia
🇪🇸
San Sebastián, Spain
Hospital Universitario de Santiago de Compostela
🇪🇸
Santiago De Compostela, Spain
Hospital Universitario 12 De Octubre
🇪🇸
Madrid, Spain