Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

• Conditions: Ischemic Stroke

• 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-05
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy

Exclusion Criteria

• Intracranial hemorrhage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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