Status:
COMPLETED
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
Lead Sponsor:
MindFrame, Inc.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00810095
Start Date
March 1 2009
End Date
April 1 2011
Last Update
July 26 2012
Active Locations (1)
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1
University of Heidelberg
Heidelberg, Germany