Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

NCT ID: NCT01560247

Last Updated: 2012-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment Group

Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal

Mechanical thrombectomy

Intervention Type: PROCEDURE

Mechanical thrombectomy using a MindFrame device

Interventions

Mechanical thrombectomy

Mechanical thrombectomy using a MindFrame device

Intervention Type: PROCEDURE

Other Intervention Names

MindFrame; Capture; Flow

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Intracranial hemorrhage

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MindFrame, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Soderman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Other Identifiers

EU-PRIISM-02

Identifier Type: -

Identifier Source: org_study_id