Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion
To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
340
Clot removal using the pRESET Thrombectomy device
Clot removal using the Solitaire Revascularization Device
Honor Health Research Institute
Scottsdale, Arizona, United States
Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2
Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) \</= 2
Time frame: 90 (+/-15) days
Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
Time frame: 24 (-8/+12) hours
Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
Proportion of subjects with eTICI 2b50 or greater flow in the target vessel post procedure with 3 or fewer passes of the assigned study device.
Time frame: During Index Procedure
Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
Proportion of patients with eTICI 2c or greater, following the first pass of the assigned study device
Time frame: During Index Procedure
Overall mortality following the index stroke
Overall mortality following the index stroke
Time frame: 90 (+/-15) days
Distribution of mRS shift across the entire spectrum of disability
Distribution of mRS shift across the entire spectrum of disability
Time frame: 90 (+/-15) days
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