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

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
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.	Immediately postprocedure	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
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.	Immediately postprocedure	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
Clinical Success	90 days postprocedure	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.

Secondary Outcome Measures

Name	Time	Method
Number of Device-related Serious Adverse Events	Treatment to 90 days postprocedure	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.