Overview

This trial is active, not recruiting.

Condition ischemic stroke
Treatment mechanical thrombectomy
Sponsor MindFrame, Inc.
Start date January 2012
End date September 2014
Trial size 1000 participants
Trial identifier NCT01560247, EU-PRIISM-02

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal
mechanical thrombectomy MindFrame
Mechanical thrombectomy using a MindFrame device

Primary Outcomes

Measure
Procedural Efficacy
time frame: Immediate postprocedure
Safety
time frame: 90 days postprocedure
Clinical Efficacy
time frame: 90 days postprocedure

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
Principal investigator Michael Soderman, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by MindFrame, Inc..