Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
- Conditions
- Ischemic Stroke
- Interventions
- Procedure: Mechanical thrombectomy
- Registration Number
- NCT01560247
- Lead Sponsor
- MindFrame, Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy
- Intracranial hemorrhage
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment Group Mechanical thrombectomy Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal
- Primary Outcome Measures
Name Time Method 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
Clinical Efficacy 90 days postprocedure The rate of modified Rankin Scale (mRS) score 0-2 at 90 days
- Secondary Outcome Measures
Name Time Method