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A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

Stroke, Acute Clinical Trial

Official title:
A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

Clinical Trial Summary

This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.

Clinical Trial Description

The study is a prospective, multi-center, single arm study that will enroll a maximum of 90 subjects, plus up to 50 roll-in subjects. A maximum of 10 sites in Europe will be involved in this study. The primary performance endpoint is successful revascularization defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure as detected by CT/MRI with an NIHSS change of >/=4. Subject will be followed through hospital discharge with a visit at Day 1 post procedure, Day 7 or prior to discharge/transfer, 30 days and 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03957278
Study type Interventional
Source MIVI Neuroscience, Inc.
Contact
Status Terminated
Phase N/A
Start date August 15, 2019
Completion date November 9, 2021
View Details
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