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

 1. NIHSS 6 to 30 within 6 hours of symptom onset

 2. Pre-stroke Modified Rankin Score ≤ 2

 3. Large Vessel Occlusion

 4. Patient/patient guardian is willing to comply with the protocol requirements and
 return to the treatment center for all required clinical evaluation.

 5. 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:

 1. Pregnancy

 2. Glucose <50mg/dL

 3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant
 therapy with INR>3.0

 4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab
 normal.

 5. Patient has baseline platelets < 30,000

 6. Evidence of rapidly improving neurological signs of stroke at time of enrollment

 7. Coma

 8. Pre-existing neurological or psychiatric disease that could confound the study results

 9. Known severe allergy to contrast media or nitinol

 10. Patient has severe sustained hypertension

 11. CT/MRI scan reveals significant mass effect with midline shift

 12. Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.

 13. Patient's anticipated life expectancy is less than 3 months

 14. Participation in another clinical investigation that could confound the evaluation of
 the study device