NCT01560247

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

March 20, 2012

Last Update Submit

April 3, 2012

Conditions

Ischemic Stroke

Keywords

StrokeIschemic StrokeRevascularizationMechanical thrombectomyNeurothrombectomy

Outcome Measures

Primary Outcomes (3)

  • 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

    Immediate postprocedure

  • Safety

    The rate of device-related serious adverse events

    90 days postprocedure

  • Clinical Efficacy

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

    90 days postprocedure

Study Arms (1)

Treatment Group

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

Procedure: Mechanical thrombectomy

Interventions

Mechanical thrombectomyPROCEDURE

Mechanical thrombectomy using a MindFrame device

Also known as: MindFrame, Capture, Flow
Treatment Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The purpose of this registry is to compile data in a "real world setting". All subjects in whom there is an attempt to use the device will be included in the registry. All subjects must be recruited according to the Mindframe System "Instructions For Use".

You may qualify if:

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

You may not qualify if:

  • Intracranial hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael Soderman, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

April 5, 2012

Record last verified: 2012-04