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

Completed

Phase 2 Results

Update History

31 Jul '12
Trial acronym was updated.
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PRIISM
Trial name was updated.
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Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
The Summary of Purpose was updated.
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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.
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The primary study objective is to assess the feasibility of using the IRIIS™ System to effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.
The description was updated.
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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.
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The primary study objective is to assess the safety of deploying the IRIIS™ System within a neurovascular thrombotic occlusion to effectively restore blood flow. 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.
Trial was updated to "Phase 2."
22 Mar '12
A location was updated in Heidelberg.
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The overall status was removed for University of Heidelberg.
6 Oct '11
The eligibility criteria were updated.
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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
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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