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

Completed

Phase 2 Results

Eligibility Criteria

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