Status:
COMPLETED
A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Lead Sponsor:
MIVI Neuroscience, Inc.
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18-85 years
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 neur...
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 ne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04089917
Start Date
September 16 2019
End Date
November 23 2021
Last Update
September 7 2023
Active Locations (4)
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1
Hospital Universitario 12 De Octubre
Madrid, Spain
2
Hospital Virgen de la Arrixaca
Murcia, Spain
3
Centro Hospitalario Universitario Donostia
San Sebastián, Spain
4
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, Spain