NCT04089917

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: MIVI Neuroscience, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Ischemic

Interventions

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

Timeline

• Start date: 2019-09-16
• Primary completion: 2021-03-30
• Completion: 2021-11-23
• First posted: 2019-09-13
• Last updated: 2023-09-07
• Results posted: 2023-09-07

Locations

4 sites across 1 country: Spain