Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study

Study Overview
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Brief Summary
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The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.

Detailed Description
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The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Official Title
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A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: MindFrame System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NIHSS 6 to 30 within 6 hours of symptom onset Pre-stroke Modified Rankin Score ≤ 2 Large Vessel Occlusion Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation. Patients must meet at least one of the following criteria: Eligible for Intravenous rt-PA Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset Patient presents within 6 hours of symptom onset Exclusion Criteria: Pregnancy Glucose <50mg/dL Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0 Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal. Patient has baseline platelets < 30,000 Evidence of rapidly improving neurological signs of stroke at time of enrollment Coma Pre-existing neurological or psychiatric disease that could confound the study results Known severe allergy to contrast media or nitinol Patient has severe sustained hypertension CT/MRI scan reveals significant mass effect with midline shift Patient's angiogram shows an arterial stenosis >50% proximal to the embolus. Patient's anticipated life expectancy is less than 3 months Participation in another clinical investigation that could confound the evaluation of the study device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br> | Device: MindFrame System<br>* Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke<br>* Other names: Neurovascular;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. | TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow | Immediately postprocedure | 
| Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram. | TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow | Immediately postprocedure | 
| Clinical Success | Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent. | 90 days postprocedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Device-related Serious Adverse Events | Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory. | Treatment to 90 days postprocedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiplegia, Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Penumbra, Functional Outcome, Aphasia, Left sided weakness, Right Sided weakness