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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.
Erasme Hospital
Brussels, Belgium
Hospital Civil Marie Curie
Charleroi, Belgium
Number of participants with successful revascularization
Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.
Time frame: intra-procedural
Rate of symptomatic intracranial haemorrhage
24 hours post-procedure as detected by CT/MRI with an NIHSS change of \>4
Time frame: 12-36 hours post procedure
Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System
Time frame: intra-procedural
Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System
Time frame: intra-procedural
Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure
Time frame: intra-procedural
Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow
Time frame: intra-procedural
Rate of procedure-related complications
Time frame: post procedure through discharge
Rate of embolization to a new vascular territory (ENT)
Time frame: intra-procedural
Good functional outcome for participants 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).
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Time frame: 30 days and 3 months post procedure
Quality of life for participants: PROMIS Scale
PROMIS Scale
Time frame: 3 months post procedure
Rate of all cause mortality
Time frame: 30 days and 3 months post procedure