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

MIVI Neuroscience

Status

Completed

Conditions

Stroke, Ischemic

Treatments

Device: Q Aspiration Catheter

Study type

Observational

Funder types

Industry

Identifiers

NCT04089917

101347

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.