Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

MindFrame, Inc.1,000 enrolled

Overview

To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Ischemic Stroke

Interventions

Mechanical thrombectomyPROCEDURE

Mechanical thrombectomy using a MindFrame device

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy Exclusion Criteria: * Intracranial hemorrhage

Outcomes

Primary Outcomes

Procedural Efficacy

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

Time frame: Immediate postprocedure

Safety

The rate of device-related serious adverse events

Time frame: 90 days postprocedure

Clinical Efficacy

The rate of modified Rankin Scale (mRS) score 0-2 at 90 days

Time frame: 90 days postprocedure

Data from ClinicalTrials.gov

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