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

MIVI Neuroscience, Inc.45 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Stroke, Ischemic

Interventions

Q Aspiration CatheterDEVICE

The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (4)

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital Virgen de la Arrixaca

Murcia, Spain

Centro Hospitalario Universitario Donostia

San Sebastián, Spain

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Outcomes

Primary Outcomes

Successful Revascularization Rate

Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel

Time frame: intra-procedural

Symptomatic Intracranial Haemorrhage Rate

Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of \>/= 4 points

Time frame: 24 hours post procedure

Secondary Outcomes

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)

Time frame: intra-procedural

Rate of Embolization to a New Neurovascular Territory (ENT)

As measured by independent Angiographic Core Lab

Time frame: 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).

Time frame: 90 days

Mortality Rate

Rate of all cause mortality

Time frame: 90 days

Data from ClinicalTrials.gov

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