Ischemic Stroke
Conditions
Keywords
Stroke, Ischemic Stroke, Revascularization, Mechanical thrombectomy, Neurothrombectomy
Brief summary
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients
Detailed description
To determine the revascularization rate, clinical efficacy and safety in a real-world setting of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
Interventions
PROCEDUREMechanical thrombectomy
Mechanical thrombectomy using a MindFrame device
Sponsors
MindFrame, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy
Exclusion criteria
* Intracranial hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy | 90 days postprocedure | The rate of modified Rankin Scale (mRS) score 0-2 at 90 days |
| Procedural Efficacy | Immediate postprocedure | The ability of the MindFrame System to restore blood flow by removing thrombus and establishing final Thrombolysis in Cerebral Infarction (TICI) 2b or 3 perfusion |
| Safety | 90 days postprocedure | The rate of device-related serious adverse events |
Outcome results
None listed