An observational study in Ischemic Stroke, sponsored by MindFrame, Inc.. Status unknown. Per ClinicalTrials.gov, last updated 2012-04-05.
Sponsored by MindFrame, Inc. · Observational
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →MindFrame, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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".
Exclusion Criteria:
Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal
Procedure: Mechanical thrombectomy
Mechanical thrombectomy using a MindFrame device
Also known as: MindFrame, Capture, Flow
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
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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MindFrame, Inc.