Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli from the neurovasculature in patients experiencing an acute ischemic stroke
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Q Revascularization System for mechanical thrombectomy
University of South Florida
Tampa, Florida, United States
Cooper University Health Care
Camden, New Jersey, United States
University at Buffalo Neurosurgery
Buffalo, New York, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Successful revascularization rate
Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure
Time frame: Procedure end
Symptomatic intracranial haemorrhage rate
Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4
Time frame: 36 hours post procedure
Successful revascularization rate with study device
Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device
Time frame: Procedure
Successful revascularization rate on the first attempt with study device
Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device
Time frame: Procedure
Procedure Time
Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow
Time frame: Procedure
ENT rate
Embolization to a new vascular territory (ENT) during procedure
Time frame: Procedure
Procedure Complications
Rate of procedure related complications
Time frame: Procedure through 90 days
ICH
Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification.
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CHU Pellegrin
Bordeaux, France
CHU Urbains
Nancy, France
CHU Bicetre Paris
Paris, France
Hôpital Purpan
Toulouse, France
Time frame: 36 hours post procedure
Good functional outcome
Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2
Time frame: 90 days post procedure
Mortality
All cause mortality
Time frame: 90 days post procedure